A Randomized, Open-Label, Multicenter Phase III Study of 5-FU/Leucovorin With or Without Concomitant SU5416 in Patients With Metastatic Colorectal Cancer
OBJECTIVES: I. Compare the median survival in patients with metastatic colorectal cancer
treated with fluorouracil and leucovorin calcium with or without SU5416. II. Compare the
time to progression, duration of response, and objective response in these patients on these
two regimens. III. Compare the percentage 6 month, 9 month, and one year survival of these
patients on these two regimens. IV. Compare the time to treatment failure in these patients
on these two regimens. V. Determine the health related quality of life of these patients on
these two regimens. VI. Compare the palliative and biologic effects of SU5416 in these
patients. VII. Determine the safety and tolerability of fluorouracil and leucovorin calcium
plus SU5416 in these patients.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to performance status (ECOG 0 vs 1), site of primary disease (colon vs rectum),
measurable or evaluable disease, and prior fluorouracil adjuvant chemotherapy (none vs at
least 1 dose). Patients are randomized to one of two treatment arms: Arm I: Patients receive
leucovorin calcium IV over 2 hours and fluorouracil IV bolus 1 hour into leucovorin calcium
administration weekly for 6 weeks. Arm II: Patients receive leucovorin calcium IV over 2
hours and fluorouracil IV bolus 1 hour into leucovorin calcium administration weekly for 6
weeks, plus SU5416 twice weekly for 8 weeks. Treatment repeats every 8 weeks in the absence
of disease progression or unacceptable toxicity. Quality of life is assessed prior to study,
at weeks 4 and 8 of each course, and then post study. Patients are followed post study at
one month and then every 2 months until death.
PROJECTED ACCRUAL: A total of 710 patients (355 per treatment arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Alison L. Hannah, MBBS
Study Chair
SUGEN
United States: Food and Drug Administration
SUGEN-SU5416.031
NCT00004252
November 1999
September 2007
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Presbyterian Healthcare | Charlotte, North Carolina 28233-3549 |
Alabama Oncology, LLC | Montgomery, Alabama 36106-2801 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
New York Medical College | Valhalla, New York 10595 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Scripps Clinic | La Jolla, California 92037 |
Michigan State University | East Lansing, Michigan 48824 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
St. Francis Hospital | San Francisco, California 94109 |
Presbyterian Hospital of Dallas | Dallas, Texas 75231 |
Comprehensive Cancer Care Specialists of Boca Raton | Boca Raton, Florida 33428 |
Office of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee | Arcadia, California 91007-7678 |
Tower Hematology Oncology Medical Group | Los Angeles, California 90048 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
Cancer Center of Boston | Boston, Massachusetts 02120 |
APN-IMPATH Research Corporation | Fort Lee, New Jersey 07024 |
Raleigh Hematology/Oncology Associates - Wake Practice | Raleigh, North Carolina 27609 |
Hematology/Oncology Associates of NE Pennsylvania, P.C. | Scranton, Pennsylvania 18510 |
Associates in Oncology & Hematology | Chattanooga, Tennessee 37404 |
Dial Research Associates, Inc. | Nashville, Tennessee 37205 |