Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed Ovarian Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of platinum-based chemotherapy with or without paclitaxel in treating patients with relapsed ovarian epithelial cancer.

Detailed Description
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OBJECTIVES: Compare survival of patients with relapsed ovarian epithelial or peritoneal cancer treated with paclitaxel and either carboplatin or cisplatin vs conventional platinum-based chemotherapy. Compare the quality of life and health economics of these regimens in these patients. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive platinum-based chemotherapy (that is familiar to the oncologist and used routinely by the center) comprising either cisplatin or carboplatin alone or cisplatin in combination with other drugs. Arm II: Patients receive paclitaxel IV over 3 hours followed by either carboplatin or cisplatin. Treatment for both arms continues every 3 weeks for up to 6 courses in the absence of unacceptable toxicity. Quality of life is assessed. Patients are followed at 6 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 800 patients will be accrued for this study.

Official Title
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A RANDOMISED TRIAL OF PACLITAXEL (TAXOL) IN COMBINATION WITH PLATINUM CHEMOTHERAPY VS. CONVENTIONAL PLATINUM-BASED CHEMOTHERAPY IN THE TREATMENT OF WOMEN WITH RELAPSED OVARIAN CANCER

Conditions
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Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: cisplatin
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Ovarian epithelial cancer or serous peritoneal carcinoma that has relapsed after prior chemotherapy Progression-free interval (from end of last treatment) of at least 6 months Measurable disease not required PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 times normal Renal: Not specified Other: No sepsis No contraindication to chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
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
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: cisplatin|nan|
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, primary peritoneal cavity cancer