Phase II Study of High Dose Cyclophosphamide, Mitoxantrone, and Carboplatin With Autologous Bone Marrow Transplantation in Refractory or Relapsed Ovarian Carcinoma
OBJECTIVES:
- Determine the response rate, duration of response, and overall survival of patients
with refractory or relapsed ovarian epithelial cancer treated with high-dose
cyclophosphamide, carboplatin, and mitoxantrone followed by autologous bone marrow
transplantation.
- Determine the nonhematopoietic toxicity of this regimen in these patients.
OUTLINE: Autologous bone marrow is harvested before study entry. Patients receive high-dose
cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8, -6, and -4
and carboplatin IV continuously on days -8 to -3 in the absence of unacceptable toxicity.
Bone marrow is reinfused on day 0 beginning at least 60 hours after completion of
carboplatin infusion.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1.5-3
years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Response rate
No
Patrick J. Stiff, MD
Study Chair
Loyola University
United States: Federal Government
LUMC-3007
NCT00002474
February 1991
October 2005
Name | Location |
---|---|
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |