Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00004860
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in treating elderly patients who have metastatic colorectal cancer.
- Detailed Description
OBJECTIVES: I. Determine the response rate of elderly patients with metastatic colorectal cancer treated with fluorouracil-uracil and leucovorin calcium (Orzel). II. Evaluate the toxicity profile of this regimen in this patient population. III. Compare response rates obtained in this study with those observed in recent phase III studies in younger patients.
OUTLINE: Patients receive oral fluorouracil-uracil and oral leucovorin calcium (Orzel) every 8 hours for 28 days. Courses repeat every 35 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 1 year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Cleveland
🇺🇸Cleveland, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Veterans Affairs Medical Center - Palo Alto
🇺🇸Palo Alto, California, United States
Beckman Research Institute, City of Hope
🇺🇸Los Angeles, California, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
🇺🇸Mount Holly, New Jersey, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Brooklyn
🇺🇸Brooklyn, New York, United States
CCOP - Sooner State
🇺🇸Tulsa, Oklahoma, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Madison
🇺🇸Madison, Wisconsin, United States
MBCCOP - San Juan
🇵🇷San Juan, Puerto Rico
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Veterans Affairs Medical Center - San Juan
🇵🇷San Juan, Puerto Rico
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Gainsville
🇺🇸Gainesville, Florida, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Nashville
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States