PHASE III COMPARISON OF TAXOTERE (DOCETAXEL) AND TAXOL (PACLITAXEL) IN PATIENTS WITH ADVANCED BREAST CANCER
OBJECTIVES:
- 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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Peter M. Ravdin, MD
Study Chair
University of Texas Health Science Center at San Antonio
United States: Federal Government
CDR0000064232
NCT00002662
August 1994
Name | Location |
---|---|
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 |