Stage IV Breast Cancer Clinical Trial
Official title:
A Phase II Trial Of Gemcitabine And Triapine In Refractory Metastatic Breast Cancer
Phase II trial to study the effectiveness of combining 3-AP with gemcitabine in treating patients who have refractory metastatic breast cancer. Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining 3-AP with gemcitabine may kill more tumor cells
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
unacceptable toxicity.
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
months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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