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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: topotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed cervical cancer, including the following cell types: Squamous cell carcinoma Adenocarcinoma Adenosquamous cell carcinoma Metastatic disease or in first relapse Not curable by surgery and/or radiotherapy with or without chemotherapy At least 1 non-irradiated measurable lesion No CNS metastases PATIENT CHARACTERISTICS: WHO performance status 0-2 ANC ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Transaminases ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases) Total bilirubin ≤ 1.5 times ULN Creatinine clearance ≥ 50 mL/min Not pregnant or nursing Fertile patients must use effective contraception No other cancer within the past 5 years except for adequately treated basal cell or squamous cell carcinoma of the skin No swallowing disorders or gastrointestinal disease resulting in an inability to take oral medication or a requirement for IV alimentation No altered intestinal absorption No peptic ulcers No nephrostomy Double-J catheter allowed None of the following cardiovascular conditions within the past 6 months: Uncontrolled hypertension Coronary artery disease NYHA class III or IV congestive heart failure Ventricular arrhythmia Unstable angina Myocardial infarction No infection or serious illness that would preclude study treatment No contraindications to study treatment No psychological, familial, sociological, or geographical condition that would preclude follow-up PRIOR CONCURRENT THERAPY: No prior cytotoxic therapy except for chemoradiotherapy or pelvic radiotherapy At least 6 months since prior platinum-based chemoradiotherapy No concurrent participation in another clinical trial that could interfere with the objectives of this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br> | Drug: carboplatin<br> <br> Drug: topotecan hydrochloride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of topotecan hydrochloride (Phase I) |  | 3 months | 
| Objective response rate (Phase II) |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma