Baltimore,
Maryland
21201
Purpose:
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 with peripheral stem cell
transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill
more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus
peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian
epithelial cancer.
Study summary:
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.
Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial
cancer who have undergone surgical debulking Stage III patients must have greater than 1
cm residual mass after surgery Must have had no more than 1 course of platinum based
chemotherapy No CNS disease
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL
Transaminases no greater than 4 times upper limit of normal No active chronic hepatitis or
liver cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: LVEF at least
50% Pulmonary: FVC, FEV1, and corrected DLCO at least 50% of predicted If unable to
complete pulmonary function tests due to pain related to the recent surgery, patient must
have a high resolution CT scan of the chest and acceptable arterial blood gases (PO2 at
least 70) Other: HIV negative No active infection requiring intravenous antibiotics Not
pregnant or nursing Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See
Disease Characteristics