A Phase II Trial Of Gemcitabine And Triapine In Refractory Metastatic Breast Cancer
OBJECTIVES: Primary I. Determine antitumor activity of 3-AP (Triapine®) and gemcitabine by
measuring tumor size in patients with refractory metastatic breast cancer.
Secondary I. Determine the safety and tolerability of this regimen in these patients. II.
Determine the time to disease progression in patients treated with this regimen.
III. Determine the effect of multidrug resistance polymorphisms on pharmacokinetics and
toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive 3-AP (Triapine®) IV over 2 hours followed by gemcitabine IV over 30 minutes
on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or
Patients are followed every 3 months until disease progression and then every 6 months for
up to 3 years after registration.
PROJECTED ACCRUAL: A total of 30-75 patients will be accrued for this study within 24
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed response (complete or partial response)
Ninety five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Up to 6 months
United States: Food and Drug Administration
|Rochester, Minnesota 55905