Ovarian Cancer Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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