SWOG-S9635 Fluorouracil Plus Ethynyluracil in Advanced Colorectal Cancer Not Responded to Fluorouracil
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
Histologically or cytologically proven metastatic colorectal cancer Prior surgery required No prior treatment for metastatic disease Disease progression while on fluorouracil adjuvant therapy Bidimensionally measurable disease Age: Over 18 Performance status: SWOG 0-2 Hematopoietic: Platelet count at least 100,000/mm3, Absolute granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 3 times ULN (no greater than 5 times ULN if liver involvement) Renal: Creatinine clearance at least 50 mL/min Other: Must be able to swallow and retain oral medications No nutritional support by gastrostomy feeding tube or parenteral support No intractable vomiting or nausea Patients with history of prior malignancy must be currently disease free and off all therapy for that malignancy Not pregnant or nursing Fertile patients must use effective contraception Biologic therapy: No concurrent immunotherapy Chemotherapy; At least 3 weeks since prior chemotherapy and recovered; No concurrent flucytosine; No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: Prior adjuvant pelvic radiation or radiation to one area of recurrence allowed At least 4 weeks since prior radiotherapy and recovered Total area of bone marrow irradiation must not exceed 25% No concurrent radiotherapy Surgery: At least 2 weeks since prior surgery for colorectal cancer and recovered No prior resection of the stomach or small intestine Other: No other concurrent anticancer therapy
Sites / Locations
- MBCCOP - University of South Alabama
- CCOP - Greater Phoenix
- Veterans Affairs Medical Center - Phoenix (Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center
- University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock (McClellan)
- Veterans Affairs Medical Center - Long Beach
- USC/Norris Comprehensive Cancer Center
- Jonsson Comprehensive Cancer Center, UCLA
- Beckman Research Institute, City of Hope
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center
- University of California Davis Medical Center
- UCSF Cancer Center and Cancer Research Institute
- CCOP - Santa Rosa Memorial Hospital
- David Grant Medical Center
- Veterans Affairs Medical Center - Denver
- University of Colorado Cancer Center
- CCOP - Atlanta Regional
- Dwight David Eisenhower Army Medical Center
- Cancer Research Center of Hawaii
- Tripler Army Medical Center
- CCOP - Central Illinois
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Loyola University Medical Center
- University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Albert B. Chandler Medical Center, University of Kentucky
- MBCCOP - LSU Medical Center
- Tulane University School of Medicine
- Veterans Affairs Medical Center - New Orleans
- Louisiana State University Health Sciences Center - Shreveport
- Veterans Affairs Medical Center - Shreveport
- Boston Medical Center
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Veterans Affairs Medical Center - Ann Arbor
- University of Michigan Comprehensive Cancer Center
- Veterans Affairs Medical Center - Detroit
- Barbara Ann Karmanos Cancer Institute
- Henry Ford Hospital
- CCOP - Grand Rapids Clinical Oncology Program
- Providence Hospital - Southfield
- Veterans Affairs Medical Center - Biloxi
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- Keesler Medical Center - Keesler AFB
- Veterans Affairs Medical Center - Kansas City
- CCOP - Kansas City
- St. Louis University Health Sciences Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- Veterans Affairs Medical Center - Albuquerque
- MBCCOP - University of New Mexico HSC
- Veterans Affairs Medical Center - Brooklyn
- Herbert Irving Comprehensive Cancer Center
- Barrett Cancer Center, The University Hospital
- Veterans Affairs Medical Center - Cincinnati
- Cleveland Clinic Cancer Center
- CCOP - Columbus
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Oklahoma Medical Research Foundation
- Veterans Affairs Medical Center - Oklahoma City
- Oregon Cancer Center at Oregon Health Sciences University
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Program
- CCOP - Greenville
- CCOP - Upstate Carolina
- Simmons Cancer Center - Dallas
- Brooke Army Medical Center
- University of Texas Medical Branch
- Texas Tech University Health Science Center
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- CCOP - Virginia Mason Research Center
- Swedish Cancer Institute
- Veterans Affairs Medical Center - Seattle
- CCOP - Northwest
Arms of the Study
Arm 1
Experimental
776C85 + 5-FU
776C85, 10mg/m2/dose, PO, Days 1-28 (BID), q 5 wk; 5-FU, 1.0mg/m2/dose, PO, Days 1-28 (BID), q 5 wk.