A Randomized, Phase II Trial of Weekly Taxol (Paclitaxel) Versus Weekly Taxol Plus Paraplatin (Carboplatin) as First-Line Chemotherapy in Patients Age 65 Years or Older With Metastatic Breast Cancer
OBJECTIVES:
- Compare the objective response rate in women treated with paclitaxel with or without
carboplatin as first-line chemotherapy for metastatic breast cancer.
- Compare the overall survival, time to disease progression, and duration of response in
these patients treated with these regimens.
- Compare the safety of these regimens in this patient population.
- Compare the quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
adjuvant chemotherapy (yes vs no) and ECOG performance status (0-1 vs 2). Patients are
randomized to one of two treatment arms.
- Arm I: Patients receive paclitaxel IV over 1 hour weekly for 3 weeks.
- Arm II:Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes
weekly for 3 weeks.
Treatment in both arms continues every 4 weeks in the absence of disease progression or
unacceptable toxicity.
Quality of life is assessed at baseline, before each course during study, and then after
completion of study.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Edith A. Perez, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000068992
NCT00025688
January 2001
Name | Location |
---|---|
St. Barnabas Medical Center | Livingston, New Jersey 07039 |
University of California Davis Cancer Center | Sacramento, California 95817 |
New Britain General Hospital | New Britain, Connecticut 06050 |
Scott and White Clinic | Temple, Texas 76508 |
Mayo Clinic | Jacksonville, Florida 32224 |
Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga, California 91730 |
Oncology Consultants | Houston, Texas 77024 |
Maine Center for Cancer Medicine and Blood Disorders | Scarborough, Maine 04074 |
Scranton Hematology-Oncology | Scranton, Pennsylvania 18510 |
Dean Medical Center | Madison, Wisconsin 53715 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
St. John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Highlands Oncology Group | Springdale, Arkansas 72764 |
Texas Cancer Care | Fort Worth, Texas 76104 |
Cancer Research Network, Inc. | Plantation, Florida 33324 |
Northern Virginia Oncology Group, P.C. | Fairfax, Virginia 22031 |
West Clinic | Memphis, Tennessee 38117 |
Monterey Bay Oncology | Monterey, California 93940 |
Center for Hematology and Oncology | Boca Raton, Florida 33486 |
MacNeal Cancer Center | Berwyn, Illinois 60402 |
Oncology Specialists, SC | Park Ridge, Illinois 60068 |
Maryland Hematology/Oncology Associates | Baltimore, Maryland 21236 |
Finger Lakes Community Cancer Center | Clifton Springs, New York 14432 |
Clinical Hematology & Oncology Service, Inc. | Akron, Ohio 44302 |
East Tennessee Oncology/Hematology, P.C. | Knoxville, Tennessee 37920 |