Trial Information

A Phase III Randomized Trial of Intravenous Paclitaxel and Cisplatin Versus Intravenous Paclitaxel, Intraperitoneal Cisplatin and Intraperitoneal Paclitaxel in Patients With Optimal Stage III Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma

OBJECTIVES: I. Compare pathological response, recurrence-free interval, and survival in
patients with optimal stage III epithelial ovarian cancer or primary peritoneal carcinoma
receiving intravenous (IV) paclitaxel and cisplatin vs IV paclitaxel and intraperitoneal
(IP) cisplatin plus IP paclitaxel. II. Compare the toxic effects and complications of these
2 treatment regimens in these patients. III. Determine the frequency and prognostic
significance of BRCA1 and BRCA2 mutations in these patients. IV. Determine the effect of
non-genetic risk factors on the course of disease in BRCA1- and BRCA2-related ovarian cancer
or primary peritoneal carcinoma. V. Compare the quality of life of these patients receiving
these treatments.

OUTLINE: This is a randomized study. Patients are stratified according to gross residual
disease (present vs absent) and whether second-look surgery will be performed at the end of
treatment (yes vs no). Blood is drawn for BRCA mutation analysis and DNA extraction before
the start of chemotherapy, but after randomization. Patients are randomized to one of two
treatment arms. Patients in arm I receive IV paclitaxel by 24-hour infusion on day 1
followed by IV cisplatin on day 2. Patients in arm II receive IV paclitaxel by 24-hour
infusion on day 1 followed by intraperitoneal (IP) cisplatin on day 2, plus IP paclitaxel on
day 8. Treatment for both arms repeats every 3 weeks for a total of 6 treatment courses.
Following chemotherapy, second look surgery is performed if selected by the patient.
Quality-of-life assessments are performed prior to randomization, prior to course 4, 3-6
weeks after the completion of course 6 and prior to second look surgery if selected, 6
months after treatment is completed, and 12 months after treatment is completed. Patients
are followed every 3 months for 2 years, then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 384 patients will be accrued for this study within 16
months.