Irinotecan and Docetaxel in Treating Patients With 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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer|
- Confirmed tumor response as measured by RECIST criteria [ Designated as safety issue: No ]
- Adverse event profile [ Designated as safety issue: Yes ]
- Distribution of progression times [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- Determine the antitumor activity of irinotecan and docetaxel, in terms of response rate, in patients with refractory metastatic breast cancer.
- 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.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 20 months.
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|Study Chair:||Edith A. Perez, MD||Mayo Clinic|
|Investigator:||Winston Tan, MD, FACP||Mayo Clinic|