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
- 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
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.
Allocation: Randomized, Primary Purpose: Treatment
Edith A. Perez, MD
United States: Federal Government
|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|