A Phase II Study of Intensive-Dose Topotecan, Ifosfamide/Mesna and Etoposide (TIME) Followed by Autologous Stem Cell Rescue in Metastatic Breast Cancer
OBJECTIVES: I. Evaluate the efficacy and toxicity of high dose topotecan with ifosfamide and
etoposide followed by autologous peripheral blood stem cell rescue in women with metastatic
breast cancer. II. Evaluate the response rates, progression free survival, engraftment, and
nonrelapse related mortality in women treated with this regimen. III. Evaluate the
pharmacokinetic profile of high dose topotecan with respect to the efficacy and toxicity of
ifosfamide and etoposide in these women.
OUTLINE: Peripheral blood stem cells (PBSC) are harvested from the patient and stored.
Patients receive ifosfamide IV over 2 hours and topotecan IV over 30 minutes on days -8 to
-6, and etoposide IV daily over 24 hours on days -5 to -3. Autologous PBSC are reinfused on
day 0. Patients are followed at 1, 3, 6, and 12 months, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study over 2 years.
Primary Purpose: Treatment
Karen K. Fields, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|