Overview

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

Status:
Completed
Trial end date:
2001-01-01
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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian cancer that has not recurred or that has not responded to previous chemotherapy.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Georgetown University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Mitoxantrone
Thiotepa
Topotecan
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV epithelial ovarian cancer
that is refractory to platinum therapy or has relapsed within 12 months after platinum
therapy Minimal residual disease by laparotomy Must have adequate number of peripheral stem
cells collected No intraabdominal, pelvic disease, or other disease greater than 1 cm No
brain metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
At least 12 weeks Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than
100,000/mm3 Hepatic: Bilirubin less than 2 times the upper limit of normal (ULN) Serum
transaminases less than 2 times ULN Renal: Creatinine clearance greater than 60 mL/min
Cardiovascular: Cardiac ejection fraction at least 45% No active angina No uncontrolled
hypertension Pulmonary: FEV1, vital capacity, and diffusion capacity greater than 50% of
predicted Other: Not HIV positive No active hepatitis B or C infection Not pregnant No
concurrent malignancy except basal cell or squamous cell carcinoma of the skin No serious
medical conditions such as uncontrolled diabetes mellitus

PRIOR CONCURRENT THERAPY: Biologic therapy: No immunotherapy within the past 4 weeks No
concurrent immunotherapy Chemotherapy: No chemotherapy within the past 4 weeks No mitomycin
within the past 6 weeks No other concurrent chemotherapy No prior anthracycline therapy
greater than 200 mg/m2 Endocrine therapy: Not specified Radiotherapy: No radiotherapy
within the past 4 weeks No concurrent radiotherapy No prior radiotherapy to the whole
abdomen Surgery: Prior surgery allowed