PHASE III COMPARISON OF TAXOTERE (DOCETAXEL) AND TAXOL (PACLITAXEL) IN PATIENTS WITH ADVANCED BREAST CANCER
- Compare the response rate in women with metastatic or locally advanced, inoperable
adenocarcinoma of the breast treated with docetaxel vs paclitaxel.
- Compare the toxicity of these regimens in these patients.
- Compare the time to disease progression, duration of response, quality of life, and
survival of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 3 weeks
in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Courses repeat every 3
weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and after courses 4 and 6.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Peter M. Ravdin, MD
University of Texas Health Science Center at San Antonio
United States: Federal Government
|George Washington University Medical Center||Washington, District of Columbia 20037|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Rush-Presbyterian-St. Luke's Medical Center||Chicago, Illinois 60612|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|Baptist Regional Cancer Center - Knoxville||Knoxville, Tennessee 37901|
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|University of Colorado Cancer Center at University of Colorado Health Sciences Center||Denver, Colorado 80010|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Baptist Regional Cancer Institute - Jacksonville||Jacksonville, Florida 32207|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Montclair Regional Cancer Center||Birmingham, Alabama 35213|
|Highlands Oncology Group, P.A. - Fayetteville||Fayetteville, Arkansas 72703|
|Northeast Arkansas Clinic||Jonesboro, Arkansas 72401-3125|
|California Cancer Care, Inc.||Greenbrae, California 94904-2007|
|Green Cancer Center at Scripps Clinic||La Jolla, California 92037|
|Sidney Kimmel Cancer Center||San Diego, California 92121|
|Norwich Cancer Center||Norwich, Connecticut 06360|
|Georgia Cancer Specialists - DeKalb||Decatur, Georgia 30033|
|James Graham Brown Cancer Center at University of Louisville||Louisville, Kentucky 40202|
|Maine Center for Cancer Medicine and Blood Disorders - Scarborough||Scarborough, Maine 04074|
|Tufts - New England Medical Center||Boston, Massachusetts 02111|
|Southfield Oncology Institute, Inc.||Southfield, Michigan 48076-3779|
|Mercy Arch Hematology Oncology, P.C.||Saint Louis, Missouri 63141|
|Blumenthal Cancer Center at Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|Carolinas Hematology-Oncology Associates||Charlotte, North Carolina 28203|
|Hematology Oncology Consultants Inc||Columbus, Ohio 43235|
|Oncology-Hematology Associates||Philadelphia, Pennsylvania 19107|
|Roger Williams Medical Center||Providence, Rhode Island 02908-4735|
|Greenville Hospital System||Greenville, South Carolina 29605|
|Charles A. Sammons Cancer Center||Dallas, Texas 75246|