A Multicenter Study of the Anti-VEGF Monoclonal Antibody Bevacizumab (AvastinĀ®) Plus 5-Fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancers That Have Progressed After Standard Chemotherapy
OBJECTIVES:
- Determine the response rate of patients treated with bevacizumab, fluorouracil, and
leucovorin calcium for stage IV colorectal cancer that has progressed after standard
chemotherapy.
- Determine the time to progression and overall survival of patients treated with this
regimen.
- Determine the safety of administering "bolus" and continuous infusion fluorouracil and
leucovorin calcium in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study. Patients receive 1 of 2 treatment
regimens.
- Regimen I: Patients receive bevacizumab IV on days 1, 15, 29, and 42 (every 2 weeks)
and leucovorin calcium (CF) IV over 2 hours and fluorouracil (5-FU) IV bolus on days 1,
8, 15, 22, 29, and 36.
- Regimen II: Patients receive bevacizumab as in regimen I and CF IV over 2 hours and
5-FU IV bolus followed by a continuous infusion over 22 hours on days 1, 2, 15, 16, 29,
30, 43, and 44.
For both regimens, courses repeat every 8 weeks in the absence of disease progression or
unacceptable toxicity.
Patients are followed for tumor response and survival.
PROJECTED ACCRUAL: Various NCI-designated Clinical Cancer Centers and other medical
institutions across the United States will participate in this study. A total of 35-125
patients will be accrued for this study within 3 months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Helen X. Chen, MD
Principal Investigator
NCI - Investigational Drug Branch
United States: Federal Government
CDR0000320506
NCT00066846
August 2003
July 2007
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Lombardi Cancer Center | Washington, District of Columbia 20007 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Meritcare Roger Maris Cancer Center | Fargo, North Dakota 58122 |
Massey Cancer Center | Richmond, Virginia 23298-0037 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
Providence Alaska Medical Center | Anchorage, Alaska 99508 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
St. Mary's/Duluth Clinic Cancer Center | Duluth, Minnesota 55805-1983 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
Cancer Care of Maine | Bangor, Maine 04401 |
Saint Joseph Mercy Health System | Ann Arbor, Michigan 48106 |
Sioux Valley Clinics - Oncology | Sioux Falls, South Dakota 57104 |