Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent Cervical Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose of topotecan hydrochloride (Phase I)
Study 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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
single arm
Intervention: carboplatin (Drug)
single arm
Intervention: topotecan hydrochloride (Drug)
Outcomes
Primary Outcomes
Maximum tolerated dose of topotecan hydrochloride (Phase I)
Time Frame: 3 months
Objective response rate (Phase II)
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported