Breast Cancer Clinical Trial
Official title:
Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as irinotecan and docetaxel, work in different
ways to stop tumor cells from dividing so they stop growing or die. Combining more than one
chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with docetaxel
works in treating patients with refractory metastatic breast cancer.
OBJECTIVES:
Primary
- Determine the antitumor activity of irinotecan and docetaxel, in terms of response
rate, in patients with refractory metastatic breast cancer.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this
regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1
and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond
CR.
Patients are followed every 2 months until disease progression and then every 6 months
thereafter.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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