A Pharmacokinetic Interaction Study Of Docetaxel (Taxotere) 75 mg/mIV On The Combination Therapy Doxorubicin (50 mg/m) And Cyclophosphamide (50 mg/m) In The Treatment Of Advanced Breast Cancer
- Determine the pharmacokinetic profile of docetaxel, doxorubicin, and cyclophosphamide
in women with advanced breast cancer.
- Compare the pharmacokinetic profile of this regimen in these patients vs the historical
pharmacokinetic profile of docetaxel.
OUTLINE: This is a randomized, open-label, crossover, multicenter study. Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 15
minutes on day 1 followed by doxorubicin IV over 15 minutes, cyclophosphamide IV over
15 minutes, and docetaxel IV over 1 hour on day 22.
- Arm II: Patients receive doxorubicin IV over 15 minutes, cyclophosphamide IV over 15
minutes, and docetaxel IV over 1 hour on day 1 followed by doxorubicin IV over 15
minutes and cyclophosphamide IV over 15 minutes on day 22.
Treatment in both arms continues in the absence of disease progression or unacceptable
toxicity. Patients may receive additional therapy at the discretion of the treating
Patients are followed at 3-4 weeks.
PROJECTED ACCRUAL: A total of 24 patients (12 per treatment arm) will be accrued for this
study within 7 months.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Beth A. Overmoyer, MD, FACP
Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|