Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin & Oral Cytoxan With G-CSF for 12 Wks; Wkly Taxol x 12
The primary objectives of the study are to evaluate the feasibility and toxicity of treatment with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks of Taxol. Feasibility will be assessed by comparing the delivered dose intensity of each drug to the delivered dose intensity in previous trials. Toxicity will be assessed by comparing the incidence and severity of toxicity with these drugs to previous trials using these drugs in the same combination. We hypothesize metronomic, dose dense treatment as given in this study will be less toxic and more effective than historical regimens using the same drugs in a less metronomic, dose dense manner.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Adjuvant Therapy for High-Risk Localized Breast Cancer With Weekly Adriamycin +/- Oral Cytoxan With Continuous G-CSF Support for 12 Weeks Followed by Weekly Taxol for 12 Weeks, Phase II|
- Delivered dose intensity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Time to treatment failure [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2001|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Weekly doxorubicin (24 mg/m2 IV) with daily oral cyclophosphamide (60 mg/m2 PO) for 12 weeks with G-CSF support days 2 - 7 of each week followed by weekly paclitaxel (80 mg/m2 IV) for 12 weeks.
80 mg/m2 IV for 12 weeks following completion of doxorubicin and cyclophosphamideDrug: Doxorubicin
24 mg/m2 IV weekly x 12Drug: Cyclophosphamide
60 mg/m2 PO daily for 12 weeksDrug: G-CSF
5 mcg per kg subcutaneously days 2 - 7 during doxorubicin and cyclophosphamide for 12 weeks
The systemic cancer treatments used in this study (Adriamycin, Cytoxan and Taxol) are all delivered in a dose dense, metronomic manner (weekly or daily). It is our hypothesis that dose dense treatment will result in optimum delivered dose intensity while minimizing toxicity. We will test these hypotheses by comparing the delivered dose intensity of the drugs to the delivered dose intensity of standard regimens. We will also compare time to relapse, survival and toxicity of this treatment to historic, standard regimens.
|United States, Washington|
|University of Washington/Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109-1023|
|Principal Investigator:||Georgiana K. Ellis, M.D.||University of Washington|