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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
80 mg/m2 IV for 12 weeks following completion of doxorubicin and cyclophosphamide
24 mg/m2 IV weekly x 12
60 mg/m2 PO daily for 12 weeks
5 mcg per kg subcutaneously days 2 - 7 during doxorubicin and cyclophosphamide for 12 weeks
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States
Delivered dose intensity
Time frame: 24 weeks
Toxicity
Time frame: 24 weeks
Time to treatment failure
Time frame: 7 years
Overall survival
Time frame: 7 years
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