Details
Stereochemistry | ABSOLUTE |
Molecular Formula | C23H23N3O5 |
Molecular Weight | 421.4458 |
Optical Activity | UNSPECIFIED |
Defined Stereocenters | 1 / 1 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
CC[C@@]1(O)C(=O)OCC2=C1C=C3N(CC4=C3N=C5C=CC(O)=C(CN(C)C)C5=C4)C2=O
InChI
InChIKey=UCFGDBYHRUNTLO-QHCPKHFHSA-N
InChI=1S/C23H23N3O5/c1-4-23(30)16-8-18-20-12(9-26(18)21(28)15(16)11-31-22(23)29)7-13-14(10-25(2)3)19(27)6-5-17(13)24-20/h5-8,27,30H,4,9-11H2,1-3H3/t23-/m0/s1
Molecular Formula | C23H23N3O5 |
Molecular Weight | 421.4458 |
Charge | 0 |
Count |
|
Stereochemistry | ABSOLUTE |
Additional Stereochemistry | No |
Defined Stereocenters | 1 / 1 |
E/Z Centers | 0 |
Optical Activity | UNSPECIFIED |
DescriptionSources: http://www.drugbank.ca/drugs/DB01030Curator's Comment: Description was created based on several sources, including
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020671s021lbl.pdf
Sources: http://www.drugbank.ca/drugs/DB01030
Curator's Comment: Description was created based on several sources, including
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020671s021lbl.pdf
Topotecan, a semi-synthetic derivative of camptothecin (a plant alkaloid obtained from the Camptotheca acuminata tree), is an anti-tumor drug with topoisomerase I-inhibitory activity similar to irinotecan. DNA topoisomerases are enzymes in the cell nucleus that regulate DNA topology (3-dimensional conformation) and facilitate nuclear processes such as DNA replication, recombination, and repair. During these processes, DNA topoisomerase I creates reversible single-stranded breaks in double-stranded DNA, allowing intact single DNA strands to pass through the break and relieve the topologic constraints inherent in supercoiled DNA. The 3'-DNA terminus of the broken DNA strand binds covalently with the topoisomerase enzyme to form a catalytic intermediate called a cleavable complex. After DNA is sufficiently relaxed and the strand passage reaction is complete, DNA topoisomerase reattaches the broken DNA strands to form the unaltered topoisomers that allow transcription to proceed. Topotecan interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells can be affected by the medicine, other effects may also occur. Unlike irinotecan, topotecan is found predominantly in the inactive carboxylate form at neutral pH and it is not a prodrug. Topotecan has the same mechanism of action as irinotecan and is believed to exert its cytotoxic effects during the S-phase of DNA synthesis. Topoisomerase I relieves torsional strain in DNA by inducing reversible single strand breaks. Topotecan binds to the topoisomerase I-DNA complex and prevents religation of these single strand breaks. This ternary complex interferes with the moving replication fork, which leads to the induction of replication arrest and lethal double-stranded breaks in DNA. As mammalian cells cannot efficiently repair these double strand breaks, the formation of this ternary complex eventually leads to apoptosis (programmed cell death). Topotecan mimics a DNA base pair and binds at the site of DNA cleavage by intercalating between the upstream (−1) and downstream (+1) base pairs. Intercalation displaces the downstream DNA, thus preventing religation of the cleaved strand. By specifically binding to the enzyme–substrate complex, Topotecan acts as an uncompetitive inhibitor. Topotecan is used for the treatment of advanced ovarian cancer in patients with disease that has recurred or progressed following therapy with platinum-based regimens. Also used as a second-line therapy for treatment-sensitive small cell lung cancer, as well as in combination with cisplatin for the treatment of stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment with surgery and/or radiation therapy. Topotecan is sold under the trade name Hycamtin.
CNS Activity
Sources: https://www.ncbi.nlm.nih.gov/pubmed/14755016
Curator's Comment: freely crosses the blood-brain barrier
Originator
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: CHEMBL1781 Sources: http://www.drugbank.ca/drugs/DB01030 |
1028.0 nM [IC50] | ||
Target ID: CHEMBL392 Sources: https://www.ncbi.nlm.nih.gov/pubmed/21463912 |
3.16 µM [IC50] | ||
Target ID: CHEMBL614697 Sources: https://www.ncbi.nlm.nih.gov/pubmed/21463912 |
0.448 µM [IC50] | ||
Target ID: CHEMBL394 Sources: https://www.ncbi.nlm.nih.gov/pubmed/21463912 |
1.1 µM [IC50] | ||
Target ID: DNA |
|||
Target ID: CHEMBL384 Sources: https://www.ncbi.nlm.nih.gov/pubmed/8182764 |
33.0 nM [IC50] |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | HYCAMTIN Approved UseHYCAMTIN for injection is a topoisomerase inhibitor indicated for:
• metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy.
• small cell lung cancer platinum-sensitive disease in patients who progressed after first-line chemotherapy.
• combination therapy with cisplatin for Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment. Launch Date1996 |
|||
Primary | HYCAMTIN Approved UseHYCAMTIN for injection is a topoisomerase inhibitor indicated for:
• metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy.
• small cell lung cancer platinum-sensitive disease in patients who progressed after first-line chemotherapy.
• combination therapy with cisplatin for Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment. Launch Date1996 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
9.29 ng/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/26291057 |
4 mg single, oral dose: 4 mg route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
61 ng × h/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/26291057 |
4 mg single, oral dose: 4 mg route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
5.23 h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/26291057 |
4 mg single, oral dose: 4 mg route of administration: Oral experiment type: SINGLE co-administered: |
TOPOTECAN plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
Funbound
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
65% |
TOPOTECAN plasma | Homo sapiens |
Doses
Dose | Population | Adverse events |
---|---|---|
10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Other AEs: Leukopenia, Leukopenia... Other AEs: Leukopenia (grade 1, 1 patient) Sources: Leukopenia (grade 2, 1 patient) Leukopenia (grade 3, 7 patients) Leukopenia (grade 4, 2 patients) Neutropenia (grade 2, 6 patients) Neutropenia (grade 3, 2 patients) Neutropenia (grade 4, 1 patient) Thrombocytopenia (grade 1, 2 patients) Thrombocytopenia (grade 2, 1 patient) Thrombocytopenia (grade 3, 1 patient) Thrombocytopenia (grade 4, 2 patients) Anemia (grade 1, 3 patients) Anemia (grade 2, 3 patients) Anemia (1 patient) |
8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Other AEs: Leukopenia, Leukopenia... Other AEs: Leukopenia (grade 1, 4 patients) Sources: Leukopenia (grade 2, 4 patients) Leukopenia (grade 3, 3 patients) Leukopenia (grade 4, 1 patient) Neutropenia (grade 1, 1 patient) Neutropenia (grade 2, 2 patients) Neutropenia (grade 3, 1 patient) Neutropenia (grade 4, 1 patient) Thrombocytopenia (grade 2, 3 patients) Thrombocytopenia (grade 3, 2 patients) Anemia (grade 1, 4 patients) Anemia (grade 2, 1 patient) Anemia (grade 3, 1 patient) Anemia (3 patients) |
2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Other AEs: Leukopenia, Leukopenia... Other AEs: Leukopenia (grade 3, 40.7%) Sources: Leukopenia (grade 4, 15.9%) Neutropenia (grade 3, 31%) Neutropenia (grade 4, 50.4%) Thrombocytopenia (grade 3, 17.7%) Thrombocytopenia (grade 4, 22.1%) Anemia (grade 3, 26.5%) Anemia (grade 4, 2.7%) Nausea (grade 1, 31.9%) Nausea (grade 2, 25%) Nausea (grade 3, 5.2%) Alopecia (grade 1, 19.8%) Alopecia (grade 2, 22.4%) Alopecia (grade 3, 4.3%) Fatigue (grade 1, 22.4%) Fatigue (grade 2, 10.3%) Fatigue (grade 3, 5.2%) Vomiting (grade 1, 12.1%) Vomiting (grade 2, 19.8%) Vomiting (grade 3, 4.3%) Vomiting (grade 4, 0.9%) Diarrhea (grade 1, 19%) Diarrhea (grade 2, 13.8%) Diarrhea (grade 3, 1.7%) Diarrhea (grade 4, 0.9%) |
1.5 mg/m2 1 times / day multiple, intravenous Recommended Dose: 1.5 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 1.5 mg/m2, 1 times / day Sources: |
unhealthy, adult n = 859 Health Status: unhealthy Condition: ovarian cancer | small cell lung cancer Age Group: adult Sex: M+F Population Size: 859 Sources: |
Other AEs: Neutropenia... |
1.5 mg/m2 1 times / day multiple, intravenous Recommended Dose: 1.5 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 1.5 mg/m2, 1 times / day Sources: |
unhealthy, adult n = 862 Health Status: unhealthy Condition: ovarian cancer | small cell lung cancer Age Group: adult Sex: M+F Population Size: 862 Sources: |
Other AEs: Thrombocytopenia, Anemia... Other AEs: Thrombocytopenia (grade 4, 20%) Sources: Anemia (grade 3-4, 11%) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Anemia | 1 patient | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Leukopenia | grade 1, 1 patient | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Thrombocytopenia | grade 1, 2 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Anemia | grade 1, 3 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Leukopenia | grade 2, 1 patient | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Thrombocytopenia | grade 2, 1 patient | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Anemia | grade 2, 3 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Neutropenia | grade 2, 6 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Thrombocytopenia | grade 3, 1 patient | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Neutropenia | grade 3, 2 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Leukopenia | grade 3, 7 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Neutropenia | grade 4, 1 patient | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Leukopenia | grade 4, 2 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Thrombocytopenia | grade 4, 2 patients | 10.5 mg/m2 1 times / 3 weeks multiple, intravenous MTD Dose: 10.5 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 10.5 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Anemia | 3 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Neutropenia | grade 1, 1 patient | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Anemia | grade 1, 4 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Leukopenia | grade 1, 4 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Anemia | grade 2, 1 patient | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Neutropenia | grade 2, 2 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Thrombocytopenia | grade 2, 3 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Leukopenia | grade 2, 4 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Anemia | grade 3, 1 patient | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Neutropenia | grade 3, 1 patient | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Thrombocytopenia | grade 3, 2 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Leukopenia | grade 3, 3 patients | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Leukopenia | grade 4, 1 patient | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Neutropenia | grade 4, 1 patient | 8.4 mg/m2 1 times / 3 weeks multiple, intravenous RP2D Dose: 8.4 mg/m2, 1 times / 3 weeks Route: intravenous Route: multiple Dose: 8.4 mg/m2, 1 times / 3 weeks Sources: |
unhealthy, 54 years (range: 34-75 years) n = 25 Health Status: unhealthy Condition: solid tumors Age Group: 54 years (range: 34-75 years) Sex: M+F Population Size: 25 Sources: |
Vomiting | grade 1, 12.1% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Diarrhea | grade 1, 19% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Alopecia | grade 1, 19.8% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Fatigue | grade 1, 22.4% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Nausea | grade 1, 31.9% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Fatigue | grade 2, 10.3% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Diarrhea | grade 2, 13.8% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Vomiting | grade 2, 19.8% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Alopecia | grade 2, 22.4% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Nausea | grade 2, 25% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Diarrhea | grade 3, 1.7% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Thrombocytopenia | grade 3, 17.7% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Anemia | grade 3, 26.5% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Neutropenia | grade 3, 31% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Alopecia | grade 3, 4.3% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Vomiting | grade 3, 4.3% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Leukopenia | grade 3, 40.7% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Fatigue | grade 3, 5.2% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Nausea | grade 3, 5.2% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Diarrhea | grade 4, 0.9% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Vomiting | grade 4, 0.9% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Leukopenia | grade 4, 15.9% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Anemia | grade 4, 2.7% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Thrombocytopenia | grade 4, 22.1% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Neutropenia | grade 4, 50.4% | 2.3 mg/m2 1 times / day multiple, oral Recommended Dose: 2.3 mg/m2, 1 times / day Route: oral Route: multiple Dose: 2.3 mg/m2, 1 times / day Sources: |
unhealthy, 62.1 years (range: 38-86 years) n = 116 Health Status: unhealthy Condition: ovarian cancer Age Group: 62.1 years (range: 38-86 years) Sex: F Population Size: 116 Sources: |
Neutropenia | grade 4, 58% | 1.5 mg/m2 1 times / day multiple, intravenous Recommended Dose: 1.5 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 1.5 mg/m2, 1 times / day Sources: |
unhealthy, adult n = 859 Health Status: unhealthy Condition: ovarian cancer | small cell lung cancer Age Group: adult Sex: M+F Population Size: 859 Sources: |
Anemia | grade 3-4, 11% | 1.5 mg/m2 1 times / day multiple, intravenous Recommended Dose: 1.5 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 1.5 mg/m2, 1 times / day Sources: |
unhealthy, adult n = 862 Health Status: unhealthy Condition: ovarian cancer | small cell lung cancer Age Group: adult Sex: M+F Population Size: 862 Sources: |
Thrombocytopenia | grade 4, 20% | 1.5 mg/m2 1 times / day multiple, intravenous Recommended Dose: 1.5 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 1.5 mg/m2, 1 times / day Sources: |
unhealthy, adult n = 862 Health Status: unhealthy Condition: ovarian cancer | small cell lung cancer Age Group: adult Sex: M+F Population Size: 862 Sources: |
PubMed
Title | Date | PubMed |
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The inhibitory effects of camptothecin, a topoisomerase I inhibitor, on collagen synthesis in fibroblasts from patients with systemic sclerosis. | 2001 |
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Developmental chemotherapy in advanced ovarian cancer: incorporation of topoisomerase-I inhibitors and perspective of the Gynecologic Oncology Group. | 2001 |
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A phase I-II trial of topotecan and gemcitabine in patients with previously treated, advanced non-small cell lung cancer (LOA-3). | 2001 |
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Phase I dose escalation study of topotecan combined with alternating schedules of paclitaxel and carboplatin in advanced solid tumors. | 2001 Apr |
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Treatment of patients with metastatic germ cell tumors relapsing after high-dose chemotherapy. | 2001 Apr |
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Antitumor activity of XR5944, a novel and potent topoisomerase poison. | 2001 Apr |
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The association of topotecan and cytarabine in the treatment of secondary or relapsed acute myeloid leukemia. | 2001 Apr |
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Circumvention of breast cancer resistance protein (BCRP)-mediated resistance to camptothecins in vitro using non-substrate drugs or the BCRP inhibitor GF120918. | 2001 Apr |
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Radiosensitization of tumor-targeted radioimmunotherapy with prolonged topotecan infusion in human breast cancer xenografts. | 2001 Apr 1 |
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Unusual potency of BN 80915, a novel fluorinated E-ring modified camptothecin, toward human colon carcinoma cells. | 2001 Apr 1 |
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Identification of breast cancer resistant protein/mitoxantrone resistance/placenta-specific, ATP-binding cassette transporter as a transporter of NB-506 and J-107088, topoisomerase I inhibitors with an indolocarbazole structure. | 2001 Apr 1 |
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Subcellular localization and distribution of the breast cancer resistance protein transporter in normal human tissues. | 2001 Apr 15 |
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Topotecan given as a 21-day infusion in the treatment of advanced ovarian cancer. | 2001 Apr 20 |
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Pharmacodynamic model of topotecan-induced time course of neutropenia. | 2001 Aug |
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Combination antiangiogenic therapy: increased efficacy in a murine model of Wilms tumor. | 2001 Aug |
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Phase I clinical trial of weekly combined topotecan and irinotecan. | 2001 Aug |
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Clonal heterogeneity of p53 mutations in ovarian cancer. | 2001 Aug |
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A novel 7-modified camptothecin analog overcomes breast cancer resistance protein-associated resistance in a mitoxantrone-selected colon carcinoma cell line. | 2001 Aug 15 |
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Resistance to topoisomerase poisons due to loss of DNA mismatch repair. | 2001 Aug 15 |
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Current treatment for ovarian cancer. | 2001 Jan |
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Paclitaxel plus topotecan treatment for patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. | 2001 Jul |
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Advances in the management of epithelial ovarian cancer. | 2001 Jul |
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Interaction between novel anticancer agents and radiation in non-small cell lung cancer cell lines. | 2001 Jul |
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UCN-01 dose-dependent inhibition of normal hyperproliferative cells in mice. | 2001 Jul |
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Effective dosing of topotecan with carboplatin in relapsed ovarian cancer: a phase I/II study. | 2001 Jul 1 |
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CCNU-dependent potentiation of TRAIL/Apo2L-induced apoptosis in human glioma cells is p53-independent but may involve enhanced cytochrome c release. | 2001 Jul 12 |
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A phase I trial of topotecan and gemcitabine administered weekly for 3 consecutive weeks to patients with advanced tumors. | 2001 Jul 15 |
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Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. | 2001 Jul 15 |
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Antisense oligonucleotides targeting the epidermal growth factor receptor inhibit proliferation, induce apoptosis, and cooperate with cytotoxic drugs in human cancer cell lines. | 2001 Jul 15 |
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Sensitivity to topoisomerase I inhibitors and cisplatin is associated with epidermal growth factor receptor expression in human cervical squamous carcinoma ME180 sublines. | 2001 Jun |
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Oligodendroglial ganglioglioma with anaplastic features arising from the thalamus. | 2001 Jun |
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Topotecan chemotherapy in patients with breast cancer and brain metastases: results of a pilot study. | 2001 Jun |
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Temporary reversal by topotecan of marked insulin resistance in a patient with myelodysplastic syndrome: case report and possible mechanism for tumor necrosis factor alpha (TNF-alpha)-induced insulin resistance. | 2001 Jun |
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Sodium phenylbutyrate induces apoptosis in human retinoblastoma Y79 cells: the effect of combined treatment with the topoisomerase I-inhibitor topotecan. | 2001 Jun |
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[Evaluation of quality of life in patients with advanced colorectal cancer treated with topotecan]. | 2001 Mar |
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The epidermal growth factor receptor as a target for cancer therapy. | 2001 Mar |
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Topoisomerase I inhibition with topotecan: pharmacologic and clinical issues. | 2001 Mar |
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Development, characterization and therapy of a disseminated model of childhood neuroblastoma in SCID mice. | 2001 Mar |
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Death receptor-independent cytochrome c release and caspase activation mediate thymidine kinase plus ganciclovir-mediated cytotoxicity in LN-18 and LN-229 human malignant glioma cells. | 2001 Mar |
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A Phase II study of topotecan in patients with squamous cell carcinoma of the cervix: a gynecologic oncology group study. | 2001 May |
|
Phase I pharmacokinetic trial and correlative in vitro phase II tumor kinetic study of Apomine (SR-45023A), a novel oral biphosphonate anticancer drug. | 2001 May |
|
Phase II trial of topotecan, carboplatin, and paclitaxel as front-line therapy in suboptimal advanced epithelial ovarian cancer. | 2001 May |
|
Repetitive high-dose topotecan, carboplatin, and paclitaxel with peripheral blood progenitor cell support in previously untreated ovarian cancer: results of a Phase I study. | 2001 May |
|
Topoisomerase IIalpha and other drug resistance markers in advanced non-small cell lung cancer. | 2001 May |
|
Synthesis and biological evaluation of novel A-ring modified hexacyclic camptothecin analogues. | 2001 May 10 |
|
Loss of expression of a new member of the DNAJ protein family confers resistance to chemotherapeutic agents used in the treatment of ovarian cancer. | 2001 May 15 |
|
Feasibility of four consecutive high-dose chemotherapy cycles with stem-cell rescue for patients with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor after craniospinal radiotherapy: results of a collaborative study. | 2001 May 15 |
|
A weekly regimen of cisplatin, paclitaxel and topotecan with granulocyte-colony stimulating factor support for patients with extensive disease small cell lung cancer: a phase II study. | 2001 May 4 |
|
High-dose topotecan, melphalan, and cyclophosphamide (TMC) with stem cell support: a new regimen for the treatment of advanced ovarian cancer. | 2001 Sep |
|
Body-surface area-based dosing does not increase accuracy of predicting cisplatin exposure. | 2001 Sep 1 |
Sample Use Guides
Ovarian cancer and small cell lung cancer: 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day course.
Cervical cancer: 0.75 mg/m2 by intravenous infusion over 30 minutes on Days 1, 2, and 3 repeated every 21 days in combination with cisplatin 50 mg/m2 on Day 1
Route of Administration:
Intravenous
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/8603419
In DC3F hamster lung fibroblasts, 2.5 uM topotecan caused redistribution of topo I to nonnucleolar regions of the nucleus.
Substance Class |
Chemical
Created
by
admin
on
Edited
Fri Dec 15 15:30:08 GMT 2023
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Record UNII |
7M7YKX2N15
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Validated (UNII)
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WHO-VATC |
QL01XX17
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EMA ASSESSMENT REPORTS |
POTACTASOL (AUTHORISED: SMALL CELL LUNG CARCINOMA, UTERINE CERVICAL NEOPLASMS)
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FDA ORPHAN DRUG |
694519
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EMA ASSESSMENT REPORTS |
HYCAMTIN (AUTHORIZED: OVARIAN NEOPLASMS, SMALL CELL LUNG CARCINOMA, UTERINE CERVICAL NEOPLASMS)
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EMA ASSESSMENT REPORTS |
EVOTOPIN (WITHDRAWN: OVARIAN NEOPLASMS
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LIVERTOX |
NBK548037
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EMA ASSESSMENT REPORTS |
TOPOTECAN HOSPIRA (AUTHORISED: SMALL CELL LUNG CARCINOMA)
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EMA ASSESSMENT REPORTS |
TOPOTECAN ACTAVIS (AUTHORISED: SMALL CELL LUNG CARCINOMA, UTERINE NEOPLASMS )
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NDF-RT |
N0000000176
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EMA ASSESSMENT REPORTS |
TOPOTECAN TEVA (AUTHORIZED: OVARIAN NEOPLASMS, SMALL CELL LUNG CARCINOMA, UTERINE CERVICAL NEOPLASMS)
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NDF-RT |
N0000175609
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WHO-ATC |
L01XX17
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NCI_THESAURUS |
C2843
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m10977
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DTXSID3042685
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METABOLITE LESS ACTIVE -> PARENT | |||
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METABOLITE ACTIVE -> PARENT | |||
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METABOLITE -> PARENT |
Topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide, were less than 2% of the administered dose.
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METABOLITE -> PARENT |
FECAL; PLASMA; URINE
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