Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy Histological or cytological requirement waived in patients who developed radiological or clinical evidence of metastatic cancer after a prior surgical resection unless: More than 5 years has elapsed since primary surgery OR Primary cancer was stage I or II Site of primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel Measurable or evaluable disease No CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL (transfusion allowed) Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled hypertension No unstable angina No symptomatic congestive heart failure No myocardial infarction within the past 6 months No serious uncontrolled arrhythmia No New York Heart Association class III or IV cardiac disease Pulmonary: No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung No pleural effusion or ascites that cause respiratory compromise (grade 2 or worse dyspnea) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active or uncontrolled infection No symptomatic sensory peripheral neuropathy No known allergy to platinum compounds No history of gastrointestinal bleeding unless it is determined to be acceptable by the enrolling physician No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the uterine cervix, or other resected malignant tumor with less than a 10% probability of tumor relapse within 3 years of diagnosis No medical or psychiatric conditions that would preclude study No colonic or small bowel disorders with uncontrolled symptoms of more than 3 loose stools per day Colostomy or ileostomy allowed at investigator's discretion PRIOR CONCURRENT THERAPY: Biologic therapy: Prior adjuvant immunotherapy for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease No concurrent sargramostim (GM-CSF) Chemotherapy: No prior chemotherapy for advanced colorectal cancer No prior standard adjuvant chemotherapy for rectal cancer Prior adjuvant fluorouracil for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease Radiotherapy: See Disease Characteristics At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy) No prior radiotherapy to more than 15% of bone marrow No prior standard adjuvant radiotherapy for rectal cancer Surgery: See Disease Characteristics At least 4 weeks since prior major surgery (e.g., laparotomy) (2 weeks for minor surgery) and recovered Insertion of a vascular access device not considered major or minor surgery Other: No other concurrent investigational agents
Sites / Locations
- Veterans Affairs Medical Center - Birmingham
- MBCCOP - Gulf Coast
- CCOP - Greater Phoenix
- Veterans Affairs Medical Center - Phoenix (Hayden)
- Mayo Clinic Hospital
- Mayo Clinic Scottsdale
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center
- University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock (McClellan)
- Cancer Center and Beckman Research Institute, City of Hope
- University of California San Diego Cancer Center
- Veterans Affairs Medical Center - Long Beach
- USC/Norris Comprehensive Cancer Center and Hospital
- Veterans Affairs Medical Center - West Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- Community Hospital of the Monterey Peninsula
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center
- Veterans Affairs Medical Center - Palo Alto
- University of California Davis Medical Center
- Veterans Affairs Medical Center - San Francisco
- UCSF Cancer Center and Cancer Research Institute
- CCOP - Santa Rosa Memorial Hospital
- Stanford University Medical Center
- David Grant Medical Center
- Columbia Medical Center of Aurora North Campus
- Penrose Cancer Center
- University of Colorado Cancer Center
- CCOP - Colorado Cancer Research Program, Inc.
- Porter Adventist Hospital
- Presbyterian-St Luke's Medical Center
- St. Joseph Hospital
- HealthOne Rose Medical Center
- Veterans Affairs Medical Center - Denver
- Swedish Medical Center
- Rocky Mountain Cancer Centers - Northern Colorado
- Poudre Valley Hospital
- Poudre Valley Radiation Oncology
- St. Mary-Corwin Regional Medical Center
- Bristol Hospital
- University of Connecticut Health Center
- St. Francis Hospital and Medical Center
- New Britain General Hospital
- Lawrence and Memorial Hospital
- William W. Backus Hospital
- Northwestern Connecticut Oncology-Hematology Associates
- CCOP - Christiana Care Health Services
- Walter Reed Army Medical Center
- University of Florida - Gainesville
- Baptist Regional Cancer Institute - Jacksonville
- University of Florida Health Science Center - Jacksonville
- Mayo Clinic
- CCOP - Mount Sinai Medical Center
- H. Lee Moffitt Cancer Center and Research Institute
- Emory University Hospital - Atlanta
- Grady Memorial Hospital
- CCOP - Atlanta Regional
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Dwight David Eisenhower Army Medical Center
- Cancer Research Center of Hawaii
- BroMenn Lifecare Center
- St. Joseph's Hospital Medical Center
- Graham Hospital Association
- Memorial Hospital
- Hematology-Oncology Associates of Illinois
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- Hematology Oncology Associates of Illinois - Lake Shore Dr
- Veterans Affairs Medical Center - Lakeside Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- Mercy Hospital and Medical Center
- University of Chicago Cancer Research Center
- CCOP - Central Illinois
- Holy Family Medical Center
- St. Anthony's Memorial Hospital
- Northwest Oncology and Hematology, S.C.
- Eureka Hospital
- CCOP - Evanston
- Galesburg Clinic
- InterCommunity Cancer Center of Western Illinois
- Galesburg Cottage Hospital
- Glenbrook Hospital
- Ingalls Memorial Hospital
- Mason District Hospital
- Hematology Oncology Associates of Illinois-Highland Park
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Hinsdale Hematology Oncology Associates
- Hopedale Medical Complex Hospital
- Silver Cross Hospital
- Joliet Oncology/Hematology Associates, Ltd.
- Saint Joseph Medical Center
- Kewanee Hospital
- Deerpath Medical Associates
- North Shore Oncology Hematology Associates
- McDonough District Hospital
- Loyola University Medical Center
- Hematology/Oncology Associates of Illinois, LLC
- Mendota Community Hospital
- Trinity Medical Center
- Morris Hospital
- BroMenn Regional Medical Center
- Community Cancer Center
- Hematology Oncology Associates of Illinois, LLC
- Community Hospital of Ottawa
- Pekin Hospital
- Illinois Oncology Research Association
- Oncology/Hematology Associates of Central Illinois, P.C.
- Affiliated Urology Specialists
- Midwest Urological Group
- Peoria Urological Associates
- Proctor Hospital
- Methodist Medical Center of Illinois
- Midwest Radiation Oncology Physicians
- St. Francis Medical Center
- Illinois Valley Community Hospital
- St. James Hospital
- Perry Memorial Hospital
- Trinity Medical Center
- Swedish-American Health System
- Sarah D. Culbertson Memorial Hospital
- Edward H. Kaplan MD and Associates
- Hematology Oncology Associates - Skokie
- Midwest Cancer Research Group, Inc.
- St. Margaret's Hospital
- Valley Cancer Center
- Carle Cancer Center
- Carle Foundation Hospital
- Therapy Associates Hematology/Oncology
- Oncology Institute of Greater Lafayette
- McFarland Clinic, P.C.
- William R. Bliss Cancer Center
- Hematology Oncology Associates of the Quad Cities
- Saint Anthony Regional Hospital
- Cedar Rapids Oncology Associates
- Mercy Medical Center
- St. Luke's Hospital
- Alegent Health Southwest Iowa Medical Center
- Des Moines General Hospital
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates
- Medical Oncology and Hematology Associates
- Mercy Hospital Medical Center
- Iowa Lutheran Hospital
- Holden Comprehensive Cancer Center at The University of Iowa
- Mercy Cancer Center
- Community Memorial Hospital
- Burgess Health Center
- Oncology & Hematology of Ottumwa, PC
- Ottumwa Regional Health Center
- Siouxland Hematology-Oncology
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas - Arkansas City
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Radiation Oncology Center
- Halstead Cancer Center of Kansas
- University of Kansas Medical Center
- Cancer Center of Kansas - Kingman
- Liberal Cancer Center of Kansas
- Cancer Center of Kansas - Newton
- Pratt Cancer Center of Kansas
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates in Women's Health - Wichita
- Wichita Clinic Cancer Medicine Associates, P.A.
- CCOP - Wichita
- Cancer Center of Kansas - Wichita
- Via Christi Regional Medical Center
- Veterans Affairs Medical Center - Wichita
- Cancer Center of Kansas - Winfield
- Veterans Affairs Medical Center - Lexington
- Albert B. Chandler Medical Center, University of Kentucky
- MBCCOP - LSU Health Sciences Center
- Tulane University School of Medicine
- Louisiana State University Health Sciences Center - Shreveport
- Veterans Affairs Medical Center - Shreveport
- Veterans Affairs Medical Center - Togus
- Anne Arundel Medical Center
- New England Medical Center Hospital
- Dana-Farber Cancer Institute
- Boston Medical Center
- Faulkner Hospital
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Lawrence Memorial Hospital of Medford/Hallmark Health Systems
- Morton Hospital & Medical Center
- University of Massachusetts Memorial Medical Center
- Bixby Medical Center
- Veterans Affairs Medical Center - Ann Arbor
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Henry Ford Hospital
- St. John Hospital and Medical Center
- Genesee Regional Medical Center
- CCOP - Grand Rapids Clinical Oncology Program
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Regional Cancer Center
- Office of E. Michael Lodish
- Community Cancer Center of Monroe
- St. Mary's Medical Center
- Balcueva Clinic
- Providence Hospital - Southfield
- St. John Macomb Hospital
- Alexandria Clinic
- Alexandria Radiation Oncology
- Brainerd Medical Center
- St. Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Duluth Clinic
- Miller-Dwan Medical Center
- St. Mary's/Duluth Clinic Health System
- Fairview-Southdale Hospital
- Fergus Falls Medical Group
- Mercy/Unity Hospitals
- Central Mesabi Medical Center
- Duluth Clinic - Hibbing
- Radiation Therapy Center
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- St. John's Hospital
- Abbott-Northwestern Hospital
- Virginia Piper Cancer Institute
- Hennepin County Medical Center - Minneapolis
- Veterans Affairs Medical Center - Minneapolis
- North Memorial Research Center
- Fairview University Medical Center - Riverside Campus
- University of Minnesota Cancer Center
- Mayo Clinic Cancer Center
- CentraCare Health Plaza
- St. Cloud Hospital
- CCOP - Metro-Minnesota
- Park Nicollet Clinic
- Regions Hospital
- Healtheast Cancer Care
- United Hospital
- Saint Francis Regional Medical Center
- Ridgeview Medical Center
- Rice Memorial Hospital
- Veterans Affairs Medical Center - Biloxi
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- Keesler Medical Center - Keesler AFB
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center - Columbia
- Veterans Affairs Medical Center - Kansas City
- CCOP - Kansas City
- St. Louis University Health Sciences Center
- Barnes-Jewish Hospital
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- Fremont Area Medical Center
- Bryan LGH Medical Center
- Prairie View Clinic
- Bryan LGH Medical Center East
- Office of Susan Hansen, M.D.
- St. Elizabeth Regional Medical Center
- Wedgewood Medical Center
- Southeast Nebraska Hematology
- Southeast Nebreska Hematology-Oncology Consultants, PC
- Williamsburg Radiation Oncology Center
- Veterans Affairs Medical Center - Omaha
- Oncology Hematology West, P.C.
- Alegent Health - Immanuel Medical Center
- Bergan Mercy Medical Center
- Creighton University Cancer Center
- St. Joseph Hospital
- University of Nebraska Medical Center
- Alegent Health-Midlands Community Hospital
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- Center for Cancer And Hematologic Disease
- Trinitas Hospital - Jersey Street Campus
- Hunterdon Regional Cancer Center
- South Jersey Regional Cancer Center
- Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
- Cancer Institute of New Jersey
- Riverview Medical Center - Booker Cancer Center
- St. Francis Medical Center
- Southern Oncology-Hematology Associates, P.A.
- Comprehensive Cancer and Hematology Associates
- Burlington County Hematology Oncology Association, P.A.
- Veterans Affairs Medical Center - Albuquerque
- MBCCOP - University of New Mexico HSC
- Albert Einstein Comprehensive Cancer Center
- Veterans Affairs Medical Center - Buffalo
- Mary Imogene Bassett Hospital
- CCOP - North Shore University Hospital
- Schneider Children's Hospital at North Shore
- Veterans Affairs Medical Center - New York
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Memorial Sloan-Kettering Cancer Center
- New York Presbyterian Hospital - Cornell Campus
- Mount Sinai Medical Center, NY
- Herbert Irving Comprehensive Cancer Center
- Rochester General Hospital
- State University of New York - Upstate Medical University
- Veterans Affairs Medical Center - Syracuse
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Lineberger Comprehensive Cancer Center, UNC
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Wake Forest University
- Bismarck Cancer Center
- Medcenter One Health System
- Mid Dakota Clinic, P.C.
- St. Alexius Medical Center
- CCOP - Merit Care Hospital
- Meritcare Roger Maris Cancer Center
- Altru Health Systems
- Altru Cancer Center
- Akron City Hospital
- Wood County Oncology Center
- Mercy Ireland Cancer Center
- Aultman Cancer Center
- Veterans Affairs Medical Center - Cincinnati
- Barrett Cancer Center, The University Hospital
- Ireland Cancer Center
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Arthur G. James Cancer Hospital - Ohio State University
- Veterans Affairs Medical Center - Dayton
- Woman Wise Blanchard Valley Regional Health Center
- Fremont Memorial Hospital
- Office of Sharon Cole, M.D.
- CCOP - Dayton
- St. Rita's Medical Center
- Lima Memorial Hospital
- North West Ohio Oncology Center
- Saint Luke's Hospital
- St. Charles Hospital
- Firelands Regional Medical Center
- North Coast Cancer Care, Inc.
- Flower Hospital - Pro Medica Health System
- Riverside Hospital
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical College of Ohio Hospital
- MCO Cancer Institute
- Haematology-Oncology Associates, Inc.
- Toledo Clinic, Inc.
- Fulton County Health Center
- Oklahoma Medical Research Foundation
- Veterans Affairs Medical Center - Oklahoma City
- CCOP - Oklahoma
- Oregon Cancer Center
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Program
- Lehigh Valley Hospital
- Muhlenberg Hospital Center
- Marion Community Hospital
- Geisinger Medical Center
- Delaware County Memorial Hospital
- DuBois Regional Medical Center
- UPMC Horizon
- Pinnacle Health Hospitals
- Wayne Memorial Hospital
- UPCI @ UPMC Lee Hospital
- Conemaugh Memorial Hospital
- Armstrong County Memorial Hospital
- Lancaster General Hospital
- Saint Mary Regional Center
- Latrobe Area Hospital
- Central Pennsylvania Hematology and Medical Oncology Associates
- Hahnemann University Hospital
- University of Pennsylvania Cancer Center
- Albert Einstein Cancer Center
- Magee-Womens Hospital
- University of Pittsburgh Medical Center
- UPMC/Passavant Hospital
- Pottstown Memorial Regional Cancer Center
- Reading Hospital and Medical Center
- Mercy Hospital Cancer Center - Scranton
- Moses Taylor Hospital
- Scranton Hematology-Oncology
- Geisinger Medical Group
- Chester County Hospital
- Geisinger Wyoming Valley Medical Center
- Rhode Island Hospital
- CCOP - Greenville
- CCOP - Upstate Carolina
- Rapid City Regional Hospital
- Sioux Valley Clinic
- Avera McKennan Hospital and University Health Center
- Avera Cancer Institute
- Sioux Valley Hospital
- University of Tennessee, Memphis Cancer Center
- Veterans Affairs Medical Center - Memphis
- Brooke Army Medical Center
- University of Texas Medical Branch
- 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
- Vermont Cancer Center
- Veterans Affairs Medical Center - White River Junction
- Veterans Affairs Medical Center - Richmond
- MBCCOP - Massey Cancer Center
- CCOP - Virginia Mason Research Center
- Swedish Cancer Institute
- Veterans Affairs Medical Center - Seattle
- CCOP - Northwest
- Madigan Army Medical Center
- Fox Valley Hematology and Oncology
- Memorial Medical Center
- Luther Hospital
- Midelfort Clinic
- St. Vincent Hospital
- Franciscan Skemp Healthcare
- Gundersen Lutheran Medical Center
- Veterans Affairs Medical Center - Madison
- Dean Medical Center
- Meriter Hospital
- University of Wisconsin Comprehensive Cancer Center
- CCOP - Marshfield Medical Research and Education Foundation
- Aurora Sinai Samaritan Medical Center
- Medical College of Wisconsin
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
- Oconomowoc Memorial Hospital
- Waukesha Memorial Hospital
- UW Cancer Center Wausau Hospital
- Cross Cancer Institute
- British Columbia Cancer Agency - Centre for the Southern Interior
- Nanaimo Cancer Clinic
- British Columbia Cancer Agency - Fraser Valley Cancer Centre
- British Columbia Cancer Agency
- British Columbia Cancer Agency - Vancouver Island Cancer Centre
- St. Boniface General Hospital
- Nova Scotia Cancer Centre
- William Osler Health Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Trillium Health Centre
- Credit Valley Hospital
- Southlake Regional Health Centre
- Peterborough Oncology Clinic
- Algoma District Medical Group
- Hotel Dieu Health Sciences Hospital - Niagara
- Northeastern Ontario Regional Cancer Centre, Sudbury
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
- Mount Sinai Hospital - Toronto
- Saint Joseph's Health Centre - Toronto
- Humber River Regional Hospital
- Queen Elizabeth Hospital, PEI
- Hopital Charles Lemoyne
- Maisonneuve-Rosemont Hospital
- Centre Hospitalier de l'Universite de Montreal
- CHUM Hopital Saint-Luc
- L'Hopital Laval
- Allan Blair Cancer Centre
- Pasqua Hospital
- Saskatoon Cancer Centre
- Lions Gate Hospital
- Centro Mamografia Hospital Oncologico
- Veterans Affairs Medical Center - San Juan
- San Juan City Hospital
- Medical Oncology Centre of Rosebank
- Pretoria Academic Hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
irinotecan + leucovorin + fluorouracil
oxaliplatin + leucovorin + fluorouracil
oxaliplatin + irinotecan
Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.