Spots Global Cancer Trial Database for Leucovorin and Fluorouracil With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Leucovorin and Fluorouracil With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
Official Title: A Randomized, Open-Label, Multicenter Phase III Study of 5-FU/Leucovorin With or Without Concomitant SU5416 in Patients With Metastatic Colorectal Cancer
Study ID: NCT00004252
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. SU5416 may stop the growth of colorectal cancer by stopping blood flow to the tumor. It is not yet known whether chemotherapy is more effective with or without SU5416 in treating metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of leucovorin and fluorouracil with or without SU5416 in treating patients who have metastatic colorectal cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alabama Oncology, LLC, Montgomery, Alabama, United States
Office of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee, Arcadia, California, United States
Scripps Clinic, La Jolla, California, United States
Tower Hematology Oncology Medical Group, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
St. Francis Hospital, San Francisco, California, United States
Comprehensive Cancer Care Specialists of Boca Raton, Boca Raton, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Cancer Center of Boston, Boston, Massachusetts, United States
Michigan State University, East Lansing, Michigan, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
APN-IMPATH Research Corporation, Fort Lee, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
New York Medical College, Valhalla, New York, United States
Presbyterian Healthcare, Charlotte, North Carolina, United States
Raleigh Hematology/Oncology Associates - Wake Practice, Raleigh, North Carolina, United States
Hematology/Oncology Associates of NE Pennsylvania, P.C., Scranton, Pennsylvania, United States
Associates in Oncology & Hematology, Chattanooga, Tennessee, United States
Dial Research Associates, Inc., Nashville, Tennessee, United States
Presbyterian Hospital of Dallas, Dallas, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Contact Details
Name: Alison L. Hannah, MBBS
Affiliation: SUGEN
Role: STUDY_CHAIR
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