A Randomized Phase III Tial Of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) As First-Line Therapy For Locally Recurrent or Metastatic Breast Cancer
OBJECTIVES:
- Compare the time to treatment failure in patients with locally recurrent or metastatic
breast cancer treated with paclitaxel with or without bevacizumab.
- Compare the objective response rate, duration of response, overall survival, and time
to progression in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to disease-free interval (no more than 24 months vs more than 24 months), number
of metastatic sites (less than 3 vs 3 or more), treatment with prior adjuvant chemotherapy
(yes vs no), and estrogen receptor status (positive vs negative vs unknown). Patients are
randomized to one of two treatment arms.
- Arm I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 followed by
bevacizumab IV over 30-90 minutes on days 1 and 15.
- Arm II: Patients receive paclitaxel as in arm I. In both arms, courses repeat every 4
weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and on day 1 of weeks 17 and 33.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 316-650 patients (158-325 per treatment arm) will be accrued
for this study within 31 months.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival
Assessed every 3 months for 2 years, then every 6 months for 3 years
No
Kathy Miller, MD
Study Chair
Indiana University Melvin and Bren Simon Cancer Center
United States: Food and Drug Administration
CDR0000069156
NCT00028990
December 2001
May 2009
Name | Location |
---|---|
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Medcenter One Health System | Bismarck, North Dakota 58501 |
CentraCare Health Plaza | Saint Cloud, Minnesota 56303 |
Altru Cancer Center | Grand Forks, North Dakota 58206 |
CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |