Overview

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer

Status:
Completed
Trial end date:
2001-02-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Maryland
University of Maryland, Baltimore
Collaborator:
University of Maryland Greenebaum Cancer Center
Treatments:
Carmustine
Melphalan
Paclitaxel
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