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
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
PROJECTED ACCRUAL: A minimum of 18 patients will be accrued for this study within 1 year.
Primary Purpose: Treatment
Deborah K. Armstrong, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Johns Hopkins Oncology Center||Baltimore, Maryland 21287|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland||Baltimore, Maryland 21201|