Trial Information

High Dose Chemotherapy With Stem Cell Rescue in Recently Diagnosed Patients With Advanced (Stage III and IV) Ovarian Cancer With > 1 cm Residual Disease After Debulking Surgery

OBJECTIVES: I. Evaluate the complete response rates, event free survival, and overall
survival of patients with recently diagnosed stage III or IV ovarian epithelial cancer
receiving carmustine plus melphalan followed by consolidation therapy after having undergone
surgical debulking. II. Evaluate the therapy related mortality associated with the
autotransplant and the consolidation therapy in these patients. III. Evaluate the quality of
life in this patient population.

OUTLINE: Patients are stratified by stage (III vs IV) and volume of residual disease (less
than 3 cm vs at least 3 cm). Approximately 10-15 days after surgery, patients receive
filgrastim (G-CSF) subcutaneously daily until all peripheral blood stem cell (PBSC)
collections have been completed. Patients then receive carmustine IV over 2 hours on day -2
and melphalan IV over 20 minutes on day -1. Peripheral blood stem cells are infused 24 hours
after melphalan on day 0. Patients receive G-CSF subcutaneously beginning on day 6 and
continuing until granulocytes have recovered. Three months after the PBSC infusion, patients
receive consolidation therapy with paclitaxel IV over 6 hours on day 2 and cisplatin IV over
24 hours on day 3. Consolidation treatment is repeated every 3 months for a total of 4
courses. Quality of life questionnaires are completed prior to PBSC transplant, before
discharge after transplant, before each consolidation treatment, and 3 months after the last
consolidation course. Patients are followed at least every 3 months for the first 2 years,
and then every 6 months thereafter.

PROJECTED ACCRUAL: An estimated 32 patients will be accrued into this study over 3-4 years.