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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.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Galesburg Clinic
Galesburg, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Start Date
April 1, 2004
Primary Completion Date
February 1, 2007
Completion Date
December 1, 2010
Last Updated
December 13, 2016
70
ACTUAL participants
docetaxel
DRUG
irinotecan hydrochloride
DRUG
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
NCT04550494
NCT04704661
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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