Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation i… (NCT00002600) | Clinical Trial Compass
CompletedPhase 1
Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
United States23 participantsStarted 1994-10-21
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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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 ce…
Trial details
NCT IDNCT00002600
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins