Cervical Cancer Clinical Trial
Official title:
Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent 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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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