Carboplatin and Topotecan in Treating Patients With Relapsed or Metastatic Cervical Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan when given together with carboplatin and to see how well they work in treating patients with relapsed or metastatic cervical cancer.
Drug: topotecan hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent Cervical Cancer|
- Maximum tolerated dose of topotecan hydrochloride (Phase I) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Objective response rate (Phase II) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|Experimental: single arm||Drug: carboplatin Drug: topotecan hydrochloride|
- To determine the maximum tolerated dose of topotecan hydrochloride when administered with carboplatin in patients with relapsed or metastatic cervical cancer. (Phase I)
- To determine the objective response rate in patients treated with this regimen. (Phase II)
- To determine the dose-limiting toxicities of this regimen in these patients. (Phase I)
- To assess the progression-free survival of patients treated with this regimen. (Phase II)
- To assess the overall survival of patients treated with this regimen. (Phase II)
- To assess the tolerability of this regimen in these patients. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study of topotecan hydrochloride followed by a phase II study.
Patients receive oral topotecan hydrochloride on days 1, 8, and 15 and carboplatin IV on day 1. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete a quality-of-life questionnaire at baseline and then every 3 months thereafter.
After completion of study therapy, patients are followed every 3 months for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807079
|Hotel Dieu de Paris|
|Paris, France, 75181|
|Principal Investigator:||Laure Chauvenet, MD||Hotel Dieu de Paris|