Trial Information

A Randomized Phase III Trial of Sequential High Dose Chemotherapy or Standard Chemotherapy for Optimally Debulked FIGO Stage III and IV Ovarian Cancer

OBJECTIVES:

- Compare the two-year progression-free survival in patients with optimally debulked
stage III or IV ovarian epithelial cancer undergoing high-dose sequential chemotherapy
vs standard chemotherapy.

- Compare the overall survival, toxicity, and quality of life in this patient population
receiving these two treatment regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive 5 courses of sequential high-dose chemotherapy as follows:

- Courses 1 and 2: Patients receive paclitaxel IV over 3 hours and cyclophosphamide
IV over 2 hours on day 1 followed by peripheral blood stem cell (PBSC) collection.
Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours
following chemotherapy and continuing until target number of PBSC are reached.

- Courses 3 and 4: Patients receive paclitaxel as in courses 1-2 and carboplatin IV
over 4 hours on day 1. At 72 hours following completion of carboplatin, patients
receive PBSC infusion. Beginning one day following PBSC infusion, patients receive
G-CSF SC until blood counts recover.

- Course 5: Patients receive paclitaxel as in courses 1 and 2 and carboplatin as in
courses 3 and 4 and melphalan IV over 15 minutes on day 2 or 3. Patients receive
PBSC and G-CSF as in courses 3 and 4.

- Treatment repeats every 3-4 weeks.

- Arm II: Patients receive standard chemotherapy consisting of carboplatin (or cisplatin)
and paclitaxel IV over 3 hours every 3 weeks for 6 courses. Patients may receive
doxorubicin or epirubicin in addition to the standard chemotherapy every 4 weeks.

Quality of life is assessed prior to therapy, at 4-6 weeks following completion of therapy,
and then at 3 months, 9 months, and 15 months.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 208 patients (104 per treatment arm) will be accrued for this
study.