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About
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. It is not yet known if carboplatin is more effective with or without gemcitabine for ovarian epithelial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with or without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has not responded to previous chemotherapy.
Full description
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to progression-free time (6-12 months vs more than 12 months), type of prior first-line therapy, and bidimensionally measurable disease (yes vs no). Patients are randomized to one of two treatment arms.
Quality of life is assessed at baseline, before each subsequent chemotherapy course, and at 50 days after study.
Patients are followed at 50 days, every 2 months for 1 year, and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial carcinoma not amenable to curative surgery or radiotherapy
No tumor of borderline malignancy
Evaluable disease outside previously irradiated area
No CNS metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
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Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Data sourced from clinicaltrials.gov
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