drugset / Trial / NCT00826891
Study of Cisplatin in Cervical Cancer Stage IVB
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a single arm, open-label study in women from China who have Advanced (stage IVB) Recurrent or Persistent cervical cancer to ⑴assess the response rate (i.e., CR + PR) of Cisplatin combined with Topotecan in treatment of advanced (stage IVB) recurrent or persistent Cervical cancer; ⑵assess the toxicities of CT regimen in treatment of cervical cancer. Prior to treatment, written informed consent should be obtained from all patients. Eligible patients will be assigned to CT regimen. The CT regimen is topotecan 0.75 mg/m2 IV during 30minutes days 1, 2, and 3; followed by cisplatin 50 mg/m2 IV on day1, repeated every 21 days. The study will consist of two phases: the safety run-in phase and study phase.
Timeline
- Start
- 2009-02
- Primary completion
- 2010-01
- Completion
- 2010-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 37.5 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Topotecan | Small molecule | 0.45 mg/m2 | Intravenous |
| Subject | Topotecan | Small molecule | 0.6 mg/m2 | Intravenous |
| Subject | Topotecan | Small molecule | 0.75 mg/m2 | Intravenous |