Overview

Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer

Status:
Completed

Trial end date:
2001-07-25

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. Bone marrow transplantation and peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with carboplatin and cyclophosphamide followed by bone marrow and peripheral stem cell transplantation in treating patients who have advanced ovarian epithelial cancer.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Treatments:

Carboplatin
Cyclophosphamide

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial malignancy of
one of the following histologies: Serous adenocarcinoma Endometrioid adenocarcinoma
Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed
epithelial carcinoma Fallopian tube and extraovarian peritoneal papillary serous tumors
also allowed Documented responsiveness (using established clinical criteria) to a
platinum-based chemotherapy regimen required Partial or complete clinical response to the
most recent chemotherapy regimen required Bone marrow aspirate and biopsy morphologically
negative for carcinoma and cellularity greater than 50% No CNS involvement

PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: GOG 0-2 Life expectancy: Not
specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least
1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL*
SGOT less than 60 IU/mL* * Unless abnormality due to metastatic involvement Renal:
Creatinine less than 2.0 mg/dL* * Unless abnormality due to metastatic involvement
Cardiovascular: LVEF at least 45% by MUGA scan No active congestive heart failure No
myocardial infarction within the past year No active arrhythmia No active angina pectoris
No uncontrolled hypertension Pulmonary: FVC and FEV at least 50% predicted Other: No
peripheral neuropathy No uncontrolled diabetes mellitus No history of other malignancy
except basal cell or squamous cell skin cancer No debilitating medical or psychiatric
illness that would preclude informed consent or study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No more than 2 prior chemotherapy regimens At least 4 weeks since prior
chemotherapy (at least 6 weeks since prior nitrosoureas) Endocrine therapy: Not specified
Radiotherapy: No prior radiotherapy for ovarian cancer Surgery: Not specified