Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- docetaxel
- Conditions
- Breast Cancer
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 70
- Locations
- 159
- Primary Endpoint
- Confirmed tumor response as measured by RECIST criteria
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
docetaxel + irinotecan
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: docetaxel
docetaxel + irinotecan
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: irinotecan hydrochloride
Outcomes
Primary Outcomes
Confirmed tumor response as measured by RECIST criteria
Time Frame: Up to 5 years
Secondary Outcomes
- Overall survival(Up to 5 years)
- Distribution of progression times(Up to 5 years)