Phase II Study Evaluating the Combination of 5-Fluorouracil, Leucovorin, Oxaliplatin, and Herceptin in the Treatment of Patients With Metastatic Colorectal Cancer Who Have Progressed After 5-FU and/or Irinotecan-Containing Therapy
OBJECTIVES:
- Determine the response rate of patients who overexpress HER-2/neu with metastatic
colorectal adenocarcinoma who have progressed on at least 1 prior, but no more than 2
prior, chemotherapy regimens for metastatic colorectal cancer treated with
fluorouracil, leucovorin calcium, oxaliplatin, and trastuzumab (Herceptin).
- Determine the time to progression of these patients treated with this regimen.
- Determine the overall toxicity of this regimen in these patients.
OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15,
and 22, followed by oxaliplatin IV over 2 hours on days 1 and 15, and then followed by
leucovorin calcium IV over 2 hours on days 1, 8, and 15. Fluorouracil IV is administered at
the midpoint of the leucovorin calcium infusion on days 1, 8, and 15. Treatment continues
every 28 days in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate
Every 2 tx cycles
No
Jeffrey W. Clark, MD
Study Chair
Massachusetts General Hospital
United States: Federal Government
CDR0000068024
NCT00006015
May 2000
February 2003
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Lombardi Cancer Center | Washington, District of Columbia 20007 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
Veterans Affairs Medical Center - Togus | Togus, Maine 04330 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |