S0030: Capecitabine in Treating Older Patients W/Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent colorectal cancer not amenable to surgical resection Measurable disease No known brain metastases by MRI or CT scan PATIENT CHARACTERISTICS: Age 70 and over OR 18 to 59 Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate transaminase) no greater than 2 times ULN Renal Creatinine no greater than 2 times ULN Creatinine clearance greater than 50 mL/min Other Not pregnant or nursing Fertile patients must use effective contraception HIV negative No known seizure disorder No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer currently in complete remission, or any other cancer for which the patient has been disease free for 5 years PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for advanced cancer Prior adjuvant chemotherapy allowed provided recurrence occurred more than 1 year after the last treatment Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other At least 4 weeks since prior sorivudine or brivudine No concurrent sorivudine or brivudine
Sites / Locations
- MBCCOP - Gulf Coast
- CCOP - Western Regional, Arizona
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock
- City of Hope Comprehensive Cancer Center
- Veterans Affairs Medical Center - Loma Linda (Pettis)
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
- University of California Davis Cancer Center
- CCOP - Santa Rosa Memorial Hospital
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Veterans Affairs Medical Center - Denver
- MBCCOP - Howard University Cancer Center
- Veterans Affairs Medical Center - Tampa (Haley)
- CCOP - Atlanta Regional
- MBCCOP - Hawaii
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- CCOP - Central Illinois
- Veterans Affairs Medical Center - Hines
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- MBCCOP - LSU Health Sciences Center
- Tulane Cancer Center at Tulane University Hospital and Clinic
- Veterans Affairs Medical Center - New Orleans
- Veterans Affairs Medical Center - Shreveport
- Louisiana State University Health Sciences Center - Shreveport
- Cancer Research Center at Boston Medical Center
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Josephine Ford Cancer Center at Henry Ford Health System
- CCOP - Grand Rapids
- CCOP - Beaumont
- Providence Cancer Institute at Providence Hospital - Southfield
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- CCOP - Kansas City
- St. Louis University Hospital Cancer 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
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Herbert Irving Comprehensive Cancer Center at Columbia University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- CCOP - Southeast Cancer Control Consortium
- Veterans Affairs Medical Center - Cincinnati
- Charles M. Barrett Cancer Center at University Hospital
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Oklahoma University Medical Center
- Cancer Institute at Oregon Health and Science University
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Oncology Program
- Veterans Affairs Medical Center - Charleston
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- University of Tennessee Cancer Institute at Methodist Central Hospital
- Veterans Affairs Medical Center - Memphis
- Harrington Cancer Center
- Veterans Affairs Medical Center - Amarillo
- Brooke Army Medical Center
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer 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
- Veterans Affairs Medical Center - Seattle
- Puget Sound Oncology Consortium
- CCOP - Northwest
Arms of the Study
Arm 1
Experimental
Capecitabine
Capecitabine 1,000 mg/m^2/dose (2,000 mg/m^2/day) BID, PO, Days 1-14 of 21 day cycle.