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Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer
This study is ongoing, but not recruiting participants.
First Received: March 7, 2000   Last Updated: August 10, 2009   History of Changes
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Collaborator: National Cancer Institute (NCI)
Information provided by: National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier: NCT00004931
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: FOLFOX regimen
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Clinical Trial Comparing 5-Fluorouracil (5-FU) Plus Leucovorin (LV) and Oxaliplatin With 5-FU Plus LV for the Treatment of Patients With Stages II and III Carcinoma of the Colon

Resource links provided by NLM:


Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

Enrollment: 2492
Study Start Date: February 2000
Estimated Study Completion Date: March 2011
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

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) weekly for 6 weeks.
  • Arm II: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and leucovorin calcium and fluorouracil as in arm I.

Treatment in both arms repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 6, 9, and 12 months; 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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/mm^3
  • Platelet count at least 100,000/mm^3

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 the past 6 months
  • No concurrent symptomatic arrhythmia

Other:

  • No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer, 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 entry
  • No grade 2 or greater peripheral neuropathy
  • No psychiatric or addictive disorder that would preclude informed consent

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004931

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

Additional Information:
Publications:
Wolmark N, Wieand S, Kuebler PJ, et al.: A phase III trial comparing FULV to FULV + oxaliplatin in stage II or III carcinoma of the colon: survival results of NSABP Protocol C-07. [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA4005, 2008.
Philip Kuebler J, Colangelo L, O'connell MJ, Smith RE, Yothers G, Begovic M, Robinson B, Seay TE, Wolmark N. Severe enteropathy among patients with stage II/III colon cancer treated on a randomized trial of bolus 5-fluorouracil/leucovorin plus or minus oxaliplatin: a prospective analysis. Cancer. 2007 Sep 12; [Epub ahead of print]
Kuebler JP, Wieand HS, O'connell MJ, Smith RE, Colangelo LH, Yothers G, Petrelli NJ, Findlay MP, Seay TE, Atkins JN, Zapas JL, Goodwin JW, Fehrenbacher L, Ramanathan RK, Conley BA, Flynn PJ, Soori G, Colman LK, Levine EA, Lanier KS, Wolmark N. Oxaliplatin Combined With Weekly Bolus Fluorouracil and Leucovorin As Surgical Adjuvant Chemotherapy for Stage II and III Colon Cancer: Results From NSABP C-07. J Clin Oncol. 2007 Apr 30; [Epub ahead of print]
Land SR, Kopec JA, Cecchini RS, Ganz PA, Wieand HS, Colangelo LH, Murphy K, Kuebler JP, Seay TE, Needles BM, Bearden JD 3rd, Colman LK, Lanier KS, Pajon ER Jr, Cella D, Smith RE, O'connell MJ, Costantino JP, Wolmark N. Neurotoxicity From Oxaliplatin Combined With Weekly Bolus Fluorouracil and Leucovorin As Surgical Adjuvant Chemotherapy for Stage II and III Colon Cancer: NSABP C-07. J Clin Oncol. 2007 Apr 30; [Epub ahead of print]
Land SR, Kopec J, Cecchini R, et al.: Patient-reported neurotoxicity with FULV versus FLOX in patients with stage II or III carcinoma of the colon: results of NSABP Protocol C-07. [Abstract] J Clin Oncol 24 (Suppl 18): A-3564, 2006.
Wolmark N, Wieand HS, Kuebler JP, et al.: A phase III trial comparing FULV to FULV + oxaliplatin in stage II or III carcinoma of the colon: results of NSABP protocol C-07. [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA3500, 246s, 2005.
Punt CJ, Buyse M, Kohne CH, Hohenberger P, Labianca R, Schmoll HJ, Pahlman L, Sobrero A, Douillard JY. Endpoints in adjuvant treatment trials: a systematic review of the literature in colon cancer and proposed definitions for future trials. J Natl Cancer Inst. 2007 Jul 4;99(13):998-1003. Epub 2007 Jun 27. Review.
Samantas E, Dervenis C, Rigatos SK. Adjuvant chemotherapy for colon cancer: evidence on improvement in survival. Dig Dis. 2007;25(1):67-75.

Responsible Party: NSABP Foundation, Inc. ( Norman Wolmark, MD )
Study ID Numbers: NSABP C-07, CDR0000067615
Study First Received: March 7, 2000
Last Updated: August 10, 2009
ClinicalTrials.gov Identifier: NCT00004931     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):
stage II colon cancer
stage III colon cancer

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Leucovorin
Rectal Diseases
Oxaliplatin
Neoplasms by Site
Vitamins
Therapeutic Uses
Micronutrients
Digestive System Neoplasms
Vitamin B Complex
Growth Substances
Intestinal Diseases
Immunosuppressive Agents
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009