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

Phase 1

Completed

• Conditions: Cervical Cancer
• Interventions: Drug: carboplatin; Drug: topotecan hydrochloride

• Registration Number: NCT00807079
• Lead Sponsor: ARCAGY/ GINECO GROUP

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Primary Completion: 2011-05
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	topotecan hydrochloride	-
single arm	carboplatin	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of topotecan hydrochloride (Phase I)	3 months
Objective response rate (Phase II)	3 months

Trial Locations

Locations (1)

Hotel Dieu de Paris; 🇫🇷 Paris, France