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Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer Clinical research trials and Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer. Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer  Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer
Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer
For Condition: stage 2 colon cancer,stage 3 colon cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , National Surgical Adjuvant Breast and Bowel Project (NSABP)
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
J.Kuebler, Study Chair, National Surgical Adjuvant Breast and Bowel Project (NSABP)
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
United States
Halifax Medical Center
Daytona Beach, Florida, 32114
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
United States
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, 75230
United States
Jewish Hospital of Cincinnati, Inc.
Cincinnati, Ohio, 45236
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Aultman Cancer Center
Canton, Ohio, 44710
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Berkshire Medical Center
Pittsfield, Massachusetts, 01201
United States
MBCCOP - San Juan
San Juan, , 00927-5800
Puerto Rico
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Cancer Treatment Centers of America at Goshen Health System
Goshen, Indiana, 46526
United States
Methodist Cancer Center - Omaha
Omaha, Nebraska, 68114
United States
Norton Healthcare System
Louisville, Kentucky, 40202-5070
United States
Sutter Cancer Center
Sacramento, California, 95816
United States
Camcare Health
Charleston, West Virginia, 25304
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
Tulane University Medical Center
New Orleans, Louisiana, 70112
United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Sutter Health West Cancer Research Group
Greenbrae, California, 94904
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589
United States
Morton Plant Mease Health Care
Clearwater, Florida, 33756
United States
University of Connecticut Health Center
Farmington, Connecticut, 06360-7106
United States
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806
United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
United States
Franklin Square Hospital Center
Baltimore, Maryland, 21237
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
St. Mary's Hospital Center
Montreal, Quebec, H3T 1M5
Canada
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, 26102
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Australasian Gastro-Intestinal Trials Group
Camperdown, New South Wales, 1450
Australia
West Suburban Hospital Medical Center
Oak Park, Illinois, 60302
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
National Naval Medical Center
Bethesda, Maryland, 20889-5000
United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, 92262
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
Albany Regional Cancer Center
Albany, New York, 12208
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Canada
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536-0093
United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415
United States
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
United States
Jewish General Hospital - Montreal
Montreal, Quebec, H3T 1E2
Canada
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
York Hospital
York, Pennsylvania, 17315
United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
United States
Illinois Masonic Medical Center
Chicago, Illinois, 60657
United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507
United States
CCOP - Dayton
Kettering, Ohio, 45429
United States
Royal Victoria Hospital - Montreal
Montreal, Quebec, H3A 1A1
Canada
CCOP - Evanston
Evanston, Illinois, 60201
United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501
United States
Medical College of Georgia Comprehensive Cancer Center
Augusta, Georgia, 30912-4000
United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207
United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Puget Sound Oncology Consortium
Seattle, Washington, 98109
United States
LaPorte Hospital
LaPorte, Indiana, 46350-0250
United States
Michigan State University
East Lansing, Michigan, 48824
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
South Pointe Hospital - Cancer Care Center
Warrensville Heights, Ohio, 44122
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45267-0502
United States
Grant/Riverside Methodist Hospitals
Columbus, Ohio, 43214
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Lincoln Medical and Mental Health Center
Bronx, New York, 10451
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Virginia Oncology Associates - Newport News
Newport News, Virginia, 23606
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Saint Mary Medical Center - Long Beach
Long Beach, California, 90813-0887
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
St. Luke's Network - Bethlehem
Bethlehem, Pennsylvania, 18015
United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110-0250
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
Akron City Hospital
Akron, Ohio, 44309
United States
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
United States
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508
United States
Huntington Memorial Hospital
Pasadena, California, 91109-7013
United States
MBCCOP-Cook County Hospital
Chicago, Illinois, 60612
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
North Idaho Cancer Center
Coeur D Alene, Idaho, 83814
United States
Clarian Health Partners Inc.
Indianapolis, Indiana, 46206-1367
United States
CCOP - Green Bay
Green Bay, Wisconsin, 54301
United States
Scripps Clinic
La Jolla, California, 92037
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Additional Information:
Study ID Numbers: CDR0000067615; NSABP-C-07
Study Start Date: February 2000
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004931
Other Stage 3 Colon Cancer Studies:
1. Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer
2. Genetic Study of Familial Factors in Patients With Colon Cancer
3. Gene Testing in Patients With Colon Cancer
4. FR901228 in Treating Patients With Previously Treated Unresectable Locally Advanced or Metastatic Colorectal Cancer
5. Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
Related Studies:
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Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer
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