Ovarian Cancer Clinical Trial
Official title:
Phase III Multicenter Study in Epithelial Ovarian Carcinoma FIGO Stage IIB-IV Comparing Treatment With Paclitaxel and Carboplatin to Paclitaxel and Carboplatin Sequentially Followed by Topotecan
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 paclitaxel plus carboplatin is more effective with or without topotecan for
ovarian epithelial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel plus
carboplatin with or without topotecan in treating patients who have stage IIB, stage III, or
stage IV ovarian epithelial cancer.
OBJECTIVES: I. Compare survival of patients with stage IIB, III, or IV ovarian epithelial
carcinoma after receiving treatment with paclitaxel and carboplatin with or without
topotecan. II. Compare progression-free survival of these patients after receiving these
treatment regimens. III. Compare the response rate and response duration in these patients
treated with these regimens. IV. Determine the toxic effects of the combination of
paclitaxel, carboplatin, and topotecan in these patients. V. Compare the toxic effects of
these treatment regimens in these patients. VI. Compare quality of life of these patients
treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and stage (stage IIB and stage III optimally debulked to no greater
than 1 cm residual tumor vs stage IV regardless of residual tumor or residual tumor greater
than 1 cm). Patients are randomized to one of two treatment arms. Arm I: Patients receive
paclitaxel IV over 3 hours and carboplatin IV over 0.5-1 hour on day 1 and topotecan IV over
0.5 hour on days 1-5. Treatment repeats every 21 days for 6 courses (topotecan is
administered for 4 courses only). Arm II: Patients receive paclitaxel and carboplatin as in
arm I. Treatment repeats every 21 days for 6 courses. Quality of life is assessed before
courses 1, 3, and 5 and at 3 weeks and 3 months after completion of treatment in both
treatment arms; before courses 1 and 3 of topotecan in arm I; and at 6 months after
completion of treatment in arm II. Patients are followed every 3 months for 2 years, every 6
months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 914 patients (457 per treatment arm) will be accrued for this
study over 2 years.
;
Allocation: Randomized, Primary Purpose: Treatment
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