Breast Cancer Clinical Trial
Official title:
A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining LY231514 plus gemcitabine in
treating women who have metastatic breast cancer.
OBJECTIVES:
- Assess the antitumor activity of pemetrexed disodium in combination with gemcitabine in
the treatment of women with metastatic breast cancer who have received an anthracycline
and a taxane in the adjuvant and/or metastatic setting and no more than 1 chemotherapy
regimen for metastatic disease (unless these were a taxane and anthracycline).
- Determine the toxicity of this regimen in this patient population.
- Determine time to progression and overall survival of these patients receiving this
regimen.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8. pemetrexed
disodium IV is administered over 10 minutes 90 minutes following gemcitabine on day 8.
Treatment continues every 21 days for a minimum of 6 courses in the absence of unacceptable
toxicity or disease progression. Patients achieving a complete response receive 2 additional
courses.
Patients are followed every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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