A Dose Seeking Trial of Topotecan Combined With High-Dose Cyclophosphamide and Carboplatin With Peripheral Blood Stem Cell Transplant for the Treatment of Relapsed Ovarian Cancer and Primary Peritoneal Cancer
- To determine the maximum tolerated dose of topotecan hydrochloride combined with
high-dose cyclophosphamide and carboplatin in the setting of autologous peripheral
blood stem cell transplantation for relapsed, recurrent, or persistent ovarian
epithelial or primary peritoneal cavity cancer.
- To assess the toxicity of this regimen.
OUTLINE: This is a dose escalation study of topotecan.
- Autologous hematopoietic stem cell collection: Patients receive filgrastim
subcutaneously (SC) daily for 5 days. Patients undergo leukapheresis per standard
practice until a minimum of 2 x10^6 CD34+ cells/kg are collected and cryopreserved.
- High-dose chemotherapy: Patients receive topotecan hydrochloride IV, cyclophosphamide
IV, and carboplatin IV over 8 hours on days -6 to -3.
- Autologous peripheral stem cell reinfusion: Patients undergo autologous peripheral
blood stem cell transplantation on day 0. Patients also receive sargramostim SC daily
beginning on day 5 and continuing until blood counts recover.
After completion of study therapy, patients are followed monthly for 3 months, every 3
months for 2 years, and then every 6 months for 5 years.
Primary Purpose: Treatment
Maximum tolerated dose of topotecan hydrochloride
Mark R. Litzow, MD
United States: Federal Government