S0030: Capecitabine in Treating Older Patients W/Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed
- Registration Number
- NCT00049335
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating older patients who have metastatic or recurrent colorectal cancer that cannot be surgically removed.
- Detailed Description
OBJECTIVES:
* Determine the feasibility of enrolling patients aged 70 and over with unresectable metastatic or recurrent colorectal cancer to a structured phase II study.
* Determine the anticancer efficacy of capecitabine, in terms of objective response rate (confirmed and unconfirmed, complete and partial responses) and 2-year survival, in these patients.
* Determine the toxicity and tolerability of this drug in these patients.
* Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status of patients treated with this drug.
* Determine the clinical pharmacology of this drug in these patients.
* Determine whether patients under 60 years of age treated with this drug have clinical pharmacologic parameters similar to those reported in the literature.
OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs 18 to 59).
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 80 patients (60 patients aged 70 and over, 20 patients aged 18 to 59) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Capecitabine capecitabine Capecitabine 1,000 mg/m\^2/dose (2,000 mg/m\^2/day) BID, PO, Days 1-14 of 21 day cycle.
- Primary Outcome Measures
Name Time Method Feasibility of enrolling patients aged 70 years or older to a Phase II trial including pharmacokinetic sampling Registration
- Secondary Outcome Measures
Name Time Method Assess whether patients under 60 years have clinical pharmacologic parameters similar to those reported in the literature 3 years Efficacy of capecitabine for management of advanced colorectal cancer patients aged 70 years or older based on objective response rate and 2 year survival 2 years Toxicity 3 years Assess parameters of clinical pharmacology of capecitabine in patients aged 70 years or older including half life value(s), AUC (area under curve) and steady state levels 3 years Explore, at a preliminary level, the feasibility of studying genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance to capecitabine 3 years
Related Research Topics
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Trial Locations
- Locations (90)
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Cancer Research Center at Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
St. Louis University Hospital Cancer Center
🇺🇸Saint Louis, Missouri, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
Providence Cancer Institute at Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
🇺🇸Phoenix, Arizona, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Loma Linda (Pettis)
🇺🇸Loma Linda, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
🇺🇸Orange, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
MBCCOP - Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Hines
🇺🇸Hines, Illinois, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Charleston
🇺🇸Charleston, South Carolina, United States
Veterans Affairs Medical Center - Memphis
🇺🇸Memphis, Tennessee, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
University of Tennessee Cancer Institute at Methodist Central Hospital
🇺🇸Memphis, Tennessee, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Puget Sound Oncology Consortium
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Amarillo
🇺🇸Amarillo, Texas, United States