Study of Cisplatin in Cervical Cancer Stage IVB
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Cisplatin Combined With Topotecan in Advanced (Stage IVB) Recurrent or Persistent Cervical Cancer|
- Response rate (CR + PR) (RECIST) [ Time Frame: 4~6 weeks after the end of treatment ] [ Designated as safety issue: Yes ]
- Toxicity [NCI CTCAE (Version 3.0)] [ Time Frame: 4~6 weeks after the end of treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||January 2010|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Drug: Cisplatin Combined With Topotecan
Patients must have specific minimum neutrophil and platelet counts before administration of Hycamtin. The dose of Hycamtin is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on days 1, 2, and 3; followed by cisplatin 50 mg/m2 by intravenous infusion on day 1 repeated every 21 days (a 21-day course).
Dosage adjustments for subsequent courses of Hycamtin in combination with cisplatin are specific for each drug.
Dose levels for cisplatin Initial dose 0 = 50 mg/m2 Dose reduction level -1 = 37.5 mg/m2 Dose reduction level -2 = 25 mg/m2
Dose levels for topotecan Initial dose 0 = 0.75 mg/m2 Dose reduction level -1 = 0.60 mg/m2 Dose reduction level -2 = 0.45 mg/m2