NCT00079118

Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer

Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	docetaxel
DRUG	irinotecan hydrochloride

Timeline

• Start date: 2004-04-01
• Primary completion: 2007-02-01
• Completion: 2010-12-01
• First posted: 2004-03-09
• Last updated: 2016-12-13

Locations

162 sites across 1 country: United States