Trial Information

A Randomized, Prospective Phase III Comparison of Paclitaxel-Carboplatin Versus Docetaxel-Carboplatin as First Line Chemotherapy in Stage Ic-IV Epithelial Ovarian Cancer

OBJECTIVES: I. Compare the progression free survival of chemotherapy naive patients with
stage IC-IV ovarian epithelial cancer following initial surgery treated with paclitaxel and
carboplatin versus docetaxel and carboplatin. II. Compare the toxic effects of these
regimens in these patients. III. Determine the overall survival, overall response rate, and
CA125 response in these patients after these regimens. IV. Determine the quality of life of
these patients on these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by residual
disease (none or microscopic vs macroscopic no greater than 2 cm vs or macroscopic greater
than 2 cm), study center, FIGO stage (IC-IV), performance status (0 vs 1 vs 2), tumor grade
(well-defined vs moderately defined vs poorly defined/undifferentiated vs unknown), interval
debulking intention (yes vs no vs randomized into OV06 trial), elevated CA125 prior to
treatment (yes vs no), and primary peritoneal cancer (yes vs no). Patients may undergo
interval debulking surgery within 4 weeks of the third course of chemotherapy, or following
6 courses of treatment. Patients undergoing interval debulking after 3 courses should resume
chemotherapy within 3 weeks of surgery. Patients are randomized into one of two treatment
arms. Arm I: Patients receive paclitaxel IV over 3 hours, immediately followed by
carboplatin IV over 1 hour. Arm II: Patients receive docetaxel IV over 1 hour, immediately
followed by carboplatin IV over 1 hour. Courses are repeated every 21 days. Treatment
continues for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with partial or complete response may receive 3 additional courses of carboplatin
alone thereafter. Quality of life is assessed at baseline, prior to each treatment course,
and then every 4 months for 2 years or until disease progression. Patients are followed
every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then
every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 1050 patients will be accrued for this study within 2.25
years.