Ovarian Cancer Clinical Trial
Official title:
A PHASE I TRIAL OF HIGH DOSE CHEMOTHERAPY WITH AUTOLOGOUS BONE MARROW AND PERIPHERAL BLOOD PROGENITOR CELL RESCUE IN PATIENTS WITH PLATINUM-SENSITIVE, CHEMOTHERAPY-RESPONSIVE EPITHELIAL OVARIAN CARCINOMA
Verified date | September 2001 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | July 25, 2001 |
Est. primary completion date | July 25, 2001 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Oncology Center | Baltimore | Maryland |
United States | Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
United States,
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