Ovarian Cancer Clinical Trial
Official title:
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
RATIONALE: Giving colony-stimulating factors, such as G-CSF help stem cells move from the
patient's bone marrow to the blood so they can be collected and stored. Combination
chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem
cells are returned to the patient to replace the blood-forming cells that were destroyed by
the chemotherapy.
PURPOSE: This randomized trial is studying the side effects and best dose of topotecan when
given together with high-dose cyclophosphamide, and carboplatin followed by an autologous
peripheral blood stem cell transplant in treating patients with recurrent ovarian cancer or
primary peritoneal cancer.
OBJECTIVES:
- 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.
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