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. It is not yet known which combination chemotherapy regimen is more effective for colon cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without oxaliplatin in treating patients who have stage II or stage III colon cancer.

Condition	Treatment or Intervention	Phase
stage III colon cancer stage II colon cancer	Procedure: chemotherapy  Drug: fluorouracil  Drug: leucovorin calcium  Drug: oxaliplatin	Phase III

Further Study Details: 

OBJECTIVES: I. Compare the efficacy of fluorouracil and leucovorin calcium with or without oxaliplatin in prolonging disease free survival and overall survival in patients with stage II or III carcinoma of the colon.

PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV (administered after 1 hour of leucovorin calcium). Treatment continues weekly for 6 weeks. Arm II: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 plus leucovorin calcium and fluorouracil as in arm I. Treatment continues every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 6, 9, and 12 months, then every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 2,472 patients will be accrued for this study within 3 years.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Previously resected potentially curable stage II or III carcinoma of the colon (T3,4; N0,1,2; M0)
• Distal extent of tumor(s) at least 12 cm from anal verge on endoscopy
• No tumors demonstrating free perforation as manifested by free air or fluid in the abdomen (walled off perforations allowed)
• Adjacent structures (e.g., bladder, small intestine, ovary) involved with primary tumor must have been curatively resected
• No prior or concurrent colon tumors other than carcinoma (sarcoma, lymphoma, carcinoid)
• No prior invasive colon or rectal malignancy
• No primary tumors involving both colon and rectum
• No isolated, distant, or noncontiguous intraabdominal metastases, even if resected
• Intestinal obstruction allowed

--Prior/Concurrent Therapy--

Biologic therapy: No concurrent biologic response modifiers

Chemotherapy:

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy: Not specified

Radiotherapy:

• No prior radiotherapy for this malignancy
• No concurrent radiotherapy for this malignancy

Surgery:

• See Disease Characteristics
• No more than 42 days since prior curative resection
• No prior noncurative surgical resection for this malignancy, except colostomy
• No prior laparoscopically-assisted colectomy (unless participating in Intergroup Protocol INT 0146 or the Australasian ALCCaS protocol)

Other:

• No other concurrent investigational drugs
• No concurrent halogenated antiviral agents (e.g., sorivudine)

--Patient Characteristics--

Age: Any age

Performance status: ECOG 0-2

Life expectancy: At least 10 years (excluding cancer)

Hematopoietic:

• Granulocyte count at least 1,500/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin normal
• Alkaline phosphatase normal
• SGOT/SGPT normal

Renal: Creatinine normal

Cardiovascular:

• No active ischemic heart disease (New York Heart Association class III-IV)
• No myocardial infarction within past 6 months
• No concurrent symptomatic arrhythmia

Other:

• No other malignancy within the past 5 years except curatively treated squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix treated by resection only, or lobular carcinoma in situ of the breast
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No nonmalignant systemic disease that would preclude study
• No grade 2 or greater peripheral neuropathy
• No psychiatric or addictive disorder that would preclude informed consent

Alabama
      Comprehensive Cancer Institute of Huntsville, Huntsville,  Alabama,  35801,  United States
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36688,  United States
Arizona
      CCOP - Greater Phoenix, Phoenix,  Arizona,  85006-2726,  United States
Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States
California
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States
      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States
      Comprehensive Cancer Centers of the Desert, Palm Springs,  California,  92262,  United States
      Huntington Memorial Hospital, Pasadena,  California,  91109-7013,  United States
      Kaiser Permanente Medical Center - Vallejo, Vallejo,  California,  94589,  United States
      Kaiser Permanente-Southern California Permanente Medical Group, San Diego,  California,  92120,  United States
      Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States
      Saint Mary Medical Center - Long Beach, Long Beach,  California,  90813-0887,  United States
      Scripps Clinic, La Jolla,  California,  92037,  United States
      Sutter Cancer Center, Sacramento,  California,  95816,  United States
      Sutter Health West Cancer Research Group, Greenbrae,  California,  94904,  United States
Colorado
      CCOP - Colorado Cancer Research Program, Inc., Denver,  Colorado,  80209-5031,  United States
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States
Connecticut
      University of Connecticut Health Center, Farmington,  Connecticut,  06360-7106,  United States
Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States
District of Columbia
      George Washington University Medical Center, Washington,  District of Columbia,  20037,  United States
Florida
      Baptist Regional Cancer Institute - Jacksonville, Jacksonville,  Florida,  32207,  United States
      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States
      Halifax Medical Center, Daytona Beach,  Florida,  32114,  United States
      MD Anderson Cancer Center Orlando, Orlando,  Florida,  32806,  United States
      Morton Plant Mease Health Care, Clearwater,  Florida,  33756,  United States
      Sarasota Memorial Hospital, Sarasota,  Florida,  34239,  United States
      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States
Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States
      Dwight David Eisenhower Army Medical Center, Fort Gordon,  Georgia,  30905-5650,  United States
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States
      Medical College of Georgia Comprehensive Cancer Center, Augusta,  Georgia,  30912-4000,  United States
Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States
Idaho
      North Idaho Cancer Center, Coeur D Alene,  Idaho,  83814,  United States
Illinois
      Alexian Brothers Medical Center, Elk Grove Village,  Illinois,  60007,  United States
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
      Illinois Masonic Medical Center, Chicago,  Illinois,  60657,  United States
      MBCCOP-Cook County Hospital, Chicago,  Illinois,  60612,  United States
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
      West Suburban Hospital Medical Center, Oak Park,  Illinois,  60302,  United States
Indiana
      Cancer Treatment Centers of America at Goshen Health System, Goshen,  Indiana,  46526,  United States
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States
      Clarian Health Partners Inc., Indianapolis,  Indiana,  46206-1367,  United States
      LaPorte Hospital, LaPorte,  Indiana,  46350-0250,  United States
Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Holden Comprehensive Cancer Center, Iowa City,  Iowa,  52242-1009,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Kentucky
      Consultants in Blood Disorders and Cancer, Louisville,  Kentucky,  40207,  United States
      Lucille Parker Markey Cancer Center, University of Kentucky, Lexington,  Kentucky,  40536-0093,  United States
      Norton Healthcare System, Louisville,  Kentucky,  40202-5070,  United States
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States
      Tulane University Medical Center, New Orleans,  Louisiana,  70112,  United States
Maine
      Eastern Maine Medical Center, Bangor,  Maine,  04401,  United States
Maryland
      Franklin Square Hospital Center, Baltimore,  Maryland,  21237,  United States
      National Naval Medical Center, Bethesda,  Maryland,  20889-5000,  United States
Massachusetts
      Baystate Medical Center, Springfield,  Massachusetts,  01199,  United States
      Berkshire Medical Center, Pittsfield,  Massachusetts,  01201,  United States
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States
Michigan
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
      Michigan State University, East Lansing,  Michigan,  48824,  United States
      William Beaumont Hospital, Royal Oak,  Michigan,  48073,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      Hennepin County Medical Center - Minneapolis, Minneapolis,  Minnesota,  55415,  United States
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States
      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
      St. Louis University Health Sciences Center, Saint Louis,  Missouri,  63110-0250,  United States
Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States
      Methodist Cancer Center - Omaha, Omaha,  Nebraska,  68114,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States
      Newark Beth Israel Medical Center, Newark,  New Jersey,  07112,  United States
New York
      Albany Regional Cancer Center, Albany,  New York,  12208,  United States
      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse,  New York,  13217,  United States
      Lincoln Medical and Mental Health Center, Bronx,  New York,  10451,  United States
North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
Ohio
      Akron City Hospital, Akron,  Ohio,  44309,  United States
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States
      Aultman Cancer Center, Canton,  Ohio,  44710,  United States
      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45267-0502,  United States
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States
      CCOP - Dayton, Kettering,  Ohio,  45429,  United States
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
      Grant/Riverside Methodist Hospitals, Columbus,  Ohio,  43214,  United States
      Jewish Hospital of Cincinnati, Inc., Cincinnati,  Ohio,  45236,  United States
      South Pointe Hospital - Cancer Care Center, Warrensville Heights,  Ohio,  44122,  United States
Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States
Oregon
      CCOP - Columbia River Program, Portland,  Oregon,  97213,  United States
Pennsylvania
      Allegheny General Hospital, Pittsburgh,  Pennsylvania,  15212-4772,  United States
      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States
      Geisinger Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107-5541,  United States
      Lehigh Valley Hospital, Allentown,  Pennsylvania,  18103,  United States
      Mercy Hospital Cancer Center - Scranton, Scranton,  Pennsylvania,  18501,  United States
      Reading Hospital and Medical Center, Reading,  Pennsylvania,  19612-6052,  United States
      St. Luke's Network - Bethlehem, Bethlehem,  Pennsylvania,  18015,  United States
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213-3489,  United States
      York Hospital, York,  Pennsylvania,  17315,  United States
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States
      Center for Oncology Research and Treatment, Medical City Hospital, Dallas,  Texas,  75230,  United States
      Joe Arrington Cancer Research and Treatment Center, Lubbock,  Texas,  79410-1894,  United States
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States
Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84112,  United States
      Utah Valley Regional Medical Center - Provo, Provo,  Utah,  84604,  United States
Vermont
      Green Mountain Oncology Group, Bennington,  Vermont,  05201,  United States
      Vermont Cancer Center, Burlington,  Vermont,  05401-3498,  United States
Virginia
      Eastern Virginia Medical School, Norfolk,  Virginia,  23507,  United States
      Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States
      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States
      Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke,  Virginia,  24014,  United States
      Virginia Oncology Associates - Newport News, Newport News,  Virginia,  23606,  United States
Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States
      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States
      Puget Sound Oncology Consortium, Seattle,  Washington,  98109,  United States
West Virginia
      Camcare Health, Charleston,  West Virginia,  25304,  United States
      Camden-Clark Memorial Hospital, Parkersburg,  West Virginia,  26102,  United States
Wisconsin
      CCOP - Green Bay, Green Bay,  Wisconsin,  54301,  United States
      CCOP - Marshfield Medical Research and Education Foundation, Marshfield,  Wisconsin,  54449,  United States
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States
      St. Luke's Medical Center, Milwaukee,  Wisconsin,  53215,  United States
      St. Vincent Hospital, Green Bay,  Wisconsin,  54307-3508,  United States
Australia, New South Wales
      Australasian Gastro-Intestinal Trials Group, Camperdown,  New South Wales,  1450,  Australia
Canada, Ontario
      Ottawa Regional Cancer Centre, Ottawa,  Ontario,  K1H 1C4,  Canada
Canada, Quebec
      Jewish General Hospital - Montreal, Montreal,  Quebec,  H3T 1E2,  Canada
      Montreal General Hospital, Montreal,  Quebec,  H3G 1A4,  Canada
      Royal Victoria Hospital - Montreal, Montreal,  Quebec,  H3A 1A1,  Canada
      St. Mary's Hospital Center, Montreal,  Quebec,  H3T 1M5,  Canada
Puerto Rico
      MBCCOP - San Juan, San Juan,  00927-5800,  Puerto Rico

Study chairs or principal investigators

J. Philip Kuebler,  Study Chair,  National Surgical Adjuvant Breast and Bowel Project (NSABP)   

Study ID Numbers:  CDR0000067615; NSABP-C-07
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004931
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08