Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent Cervical Cancer
- 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
- 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
- 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
After completion of study therapy, patients are followed every 3 months for 1 year.
Primary Purpose: Treatment
Maximum tolerated dose of topotecan hydrochloride (Phase I)
Laure Chauvenet, MD
Hotel Dieu de Paris
United States: Federal Government