NCT00807079

Carboplatin and Topotecan in Treating Patients With Relapsed or Metastatic Cervical Cancer

Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent Cervical Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: ARCAGY/ GINECO GROUP · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	topotecan hydrochloride

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-05-01
• First posted: 2008-12-11
• Last updated: 2014-10-29

Locations

1 site across 1 country: France