Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent Cervical Cancer
Overview
- Phase
- Phase 1
- Intervention
- carboplatin
- Conditions
- Cervical Cancer
- Sponsor
- ARCAGY/ GINECO GROUP
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose of topotecan hydrochloride (Phase I)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
OBJECTIVES: Primary * 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) Secondary * 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
single arm
Intervention: carboplatin
single arm
Intervention: topotecan hydrochloride
Outcomes
Primary Outcomes
Maximum tolerated dose of topotecan hydrochloride (Phase I)
Time Frame: 3 months
Objective response rate (Phase II)
Time Frame: 3 months