Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
|ClinicalTrials.gov Identifier: NCT00002600|
Recruitment Status : Completed
First Posted : April 6, 2004
Last Update Posted : April 26, 2011
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 or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|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|
|Study Start Date :||September 1994|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002600
|United States, Maryland|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland|
|Baltimore, Maryland, United States, 21201|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21231|
|Study Chair:||Deborah K. Armstrong, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|