Ovarian Cancer Clinical Trial
Official title:
A RANDOMIZED, CONTROLLED TRIAL OF SALVAGE THERAPY WITH PACLITAXEL AND CARBOPLATIN VERSU SALVAGE THERAPY WITH STEM CELL SUPPORTED HIGH-DOSE CARBOPLATIN, MITOXANTRONE AND CYCLOPHOSPHAMIDE IN PATIENTS WITH PERSISTENT LOW VOLUME OVARIAN CANCER AND RESPONSE TO PRIMARY THERAPY
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Peripheral stem cell transplantation may be able to replace
immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor
cells. It is not yet known whether chemotherapy alone is more effective than chemotherapy
plus peripheral stem cell transplantation for ovarian epithelial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and
carboplatin with that of carboplatin, mitoxantrone, and cyclophosphamide followed by
peripheral stem cell transplantation in treating patients who have persistent stage III or
stage IV ovarian epithelial cancer.
OBJECTIVES: I. Compare progression-free and overall survival of patients with
drug-sensitive, low-volume ovarian cancer that is persistent following standard therapy
treated with salvage therapy comprising standard-dose paclitaxel and carboplatin vs
high-dose carboplatin, mitoxantrone, and cyclophosphamide followed by bone marrow
reconstitution. II. Compare the toxic effects of these two salvage regimens. III. Compare
selected health-related aspects of quality of life in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating
center and disease state at reassessment laparotomy. Patients are randomized to one of two
treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and carboplatin
IV continuously on days 1-5 every 3 weeks for a total of 6 courses. Arm II: Patients receive
cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8, -6, and -4,
and carboplatin IV continuously on days -8 through -4, followed by rescue with autologous
bone marrow or peripheral blood stem cells on day 0. Quality of life is assessed at
baseline, at 3 and 9 weeks after starting treatment, and every 3 months for an additional 5
assessments regardless of disease progression.
PROJECTED ACCRUAL: A total of 275 patients will be accrued over approximately 60 months.
;
Allocation: Randomized, Primary Purpose: Treatment
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