Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer (CTC)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating women who have breast cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Cyclophosphamide, Thiotepa, and Carboplatin (CTC) as a Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Breast Cancer|
- relapse-free survival [ Time Frame: five years post transplant ] [ Designated as safety issue: No ]relapse free survival determined by the Kaplan-Meier product-limit method
- Rate of Grade III/IV toxicities [ Time Frame: five years post transplant ] [ Designated as safety issue: No ]rate of grade III/IV toxicity
|Study Start Date:||July 1995|
|Study Completion Date:||July 2007|
|Primary Completion Date:||August 2001 (Final data collection date for primary outcome measure)|
CTC Conditioning Regimen
Cyclophosphamide Thiotepa Carboplatin
Carboplatin will be given at a dose of 267 mg/m2 in D5 W IV over one hour daily on days -6, -5, and -4. (Total dose 800 mg/m2)
Other Name: Paraplatin(R)Drug: Cyclophosphamide
Cyclophosphamide will be given at a dose of 2000 mg/m2 in NS IV over one hour daily on days -6, -5, and -4. (Total dose 6000 mg/m2)Drug: Thiotepa
Thiotepa will be given at a dose of 167 mg/m2 in NS IV over one hour daily on days -6, -5, and -4. (Total dose 500 mg/m2 )
OBJECTIVES: I. Determine long term remission rates as measured by disease free survival in women with breast cancer treated with cyclophosphamide, thiotepa, and carboplatin followed by autologous hematopoietic stem cell transplantation. II. Determine the safety and efficacy of this combination chemotherapy regimen in this patient population.
OUTLINE: Peripheral blood stem cells (PBSC) are collected. Patients sequentially receive cyclophosphamide IV over 1 hour, thiotepa IV over 1 hour, and carboplatin IV over 1 hour on days -6 to -4. PBSC are reinfused on day 0. Patients are followed at 3 months, 6 months, 1 year, and then annually thereafter.
PROJECTED ACCRUAL: At least 40 patients with 4-9 positive lymph nodes and at least 50 patients with 10 positive lymph nodes will be accrued for this study.
|United States, Florida|
|Halifax Medical Center|
|Daytona Beach, Florida, United States, 32114|
|Florida Cancer Specialists|
|Fort Myers, Florida, United States, 33901|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Principal Investigator:||Claudio Anasetti, MD||Moffitt Cancer Center|