Ovarian Cancer Clinical Trial
Official title:
Phase III Randomized Trial of 12 Months vs. 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. It is not yet known whether giving paclitaxel for a shorter
period of time is as effective as a standard course of treatment for advanced ovarian
cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel given for 3
months with that of paclitaxel given for 12 months in treating patients who have stage III
or stage IV ovarian, fallopian tube, or primary peritoneal cancer.
OBJECTIVES: I. Compare the effect of continuing paclitaxel for 12 months versus 3 months on
progression free survival and overall survival in women with advanced ovarian, fallopian
tube, or peritoneal cancer who attained complete remission on initial platinum (carboplatin
or cisplatin) and paclitaxel based chemotherapy. II. Assess the toxic effects associated
with prolonged paclitaxel administration in these patients.
OUTLINE: This is a randomized study. Patients are stratified by stage (optimal stage III vs
suboptimal stage III vs stage IV), prior treatments with paclitaxel (over at least 24 hours
vs over less than 24 hours), and age (65 and under vs over 65). Patients are randomized to
one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1.
Treatment continues every 4 weeks for 3 courses in the absence of disease progression or
unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours on day 1.
Treatment continues every 4 weeks for 12 courses in the absence of disease progression or
unacceptable toxicity. Patients are followed every 3 months until disease progression or 1
year from registration, then every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study
within 5 years.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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