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Sponsored by: |
Sidney Kimmel Comprehensive Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002600 |
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.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: carboplatin Drug: cyclophosphamide Drug: filgrastim Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
Estimated Enrollment: | 18 |
Study Start Date: | September 1994 |
OBJECTIVES: I. Determine the maximum tolerated dose of carboplatin when combined with cyclophosphamide as high-dose therapy followed by autologous bone marrow and peripheral blood stem cell rescue in patients with platinum sensitive ovarian epithelial carcinoma. II. Determine the efficacy of this regimen in these patients.
OUTLINE: This is a dose escalation study of carboplatin. Autologous bone marrow (ABM) is harvested on day -11, filgrastim (G-CSF) is administered subcutaneously (SC) on days -11 to -7, and autologous peripheral blood stem cells (PBSC) are harvested on day -6. Patients receive high dose chemotherapy comprising carboplatin IV over 15 minutes on days -5 and -4 and cyclophosphamide IV over 1 hour on days -3 and -2. PBSC are reinfused on day -1, ABM is reinfused on day 0, and G-CSF is administered SC beginning on day 7 and continuing until blood counts recover. Cohorts of 2-4 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 10% of patients experience dose-limiting toxicity. A minimum of 6 patients receive carboplatin at the MTD. Patients are followed at 1 month and then every 3 months for 5 years.
PROJECTED ACCRUAL: A minimum of 18 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
United States, Maryland | |
Johns Hopkins Oncology Center | |
Baltimore, Maryland, United States, 21231 | |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |
Baltimore, Maryland, United States, 21201 |
Study Chair: | Deborah K. Armstrong, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000063839, JHOC-9434, NCI-V94-0544 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002600 |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer ovarian undifferentiated adenocarcinoma ovarian mixed epithelial carcinoma ovarian serous cystadenocarcinoma ovarian mucinous cystadenocarcinoma |
ovarian endometrioid adenocarcinoma ovarian clear cell cystadenocarcinoma fallopian tube cancer peritoneal cavity cancer |
Cystadenocarcinoma, Serous Gonadal Disorders Urogenital Neoplasms Cyclophosphamide Ovarian Diseases Ovarian epithelial cancer Carcinoma, Endometrioid Dental Caries Genital Diseases, Female Peritoneal Diseases Endocrine Gland Neoplasms Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms |
Genital Neoplasms, Female Endocrine System Diseases Carboplatin Abdominal Neoplasms Recurrence Fallopian Tube Neoplasms Carcinoma Fallopian Tube Diseases Digestive System Diseases Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Fallopian tube cancer Adenocarcinoma |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases |
Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |