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Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00008281
Recruitment Status : Unknown
Verified April 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 16, 2004
Last Update Posted : January 6, 2014
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for metastatic colorectal cancer.

PURPOSE: Phase III trial to compare the effectiveness of three chemotherapy regimens in treating patients who have metastatic colorectal cancer.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Phase 3

Detailed Description:

OBJECTIVES: I. Compare the overall survival of patients with metastatic colorectal carcinoma treated with fluorouracil and leucovorin calcium with vs without oxaliplatin vs oxaliplatin alone. II. Compare the response rate, time to tumor-related symptomatic worsening, time to disease progression, onset and duration of complete and partial responses, and duration of disease stabilization in patients treated with these regimens. III. Determine the safety profile of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs (1 vs 2 or more), and LDH value (up to 1.5 times upper limit of normal (ULN) vs greater than 1.5 times ULN). Patients are randomized to one of three treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours on day 1. Arm III: Patients receive oxaliplatin IV concurrently with leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on day 1. Leucovorin calcium and fluorouracil are administered alone on day 2 on the same schedule as on day 1. Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days, every 2 weeks for up to 3 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 786 patients (262 per arm) will be accrued for this study within 12 months.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Randomized, Three-Arm Study Of 5-Fluorouracil (5-FU) Plus Leucovorin (LV) Or Oxaliplatin Or A Combination Of (5-Fu) LV + Oxaliplatin As Second-Line Treatment Of Metastatic Colorectal Carcinoma
Study Start Date : October 2000

Resource links provided by the National Library of Medicine






Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum that is not amenable to potentially curative therapy (e.g., inoperable metastatic disease) At least 1 unidimensionally measurable lesion at least 20 mm in diameter by conventional CT or MRI scan or at least 10 mm in diameter by spiral CT scan Progressive disease by CT or MRI scan during or no more than 6 months after the last dose of prior first-line irinotecan, fluorouracil, and leucovorin calcium (Saltz regimen) for metastatic disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 3 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled high blood pressure No unstable angina, symptomatic congestive heart failure, or serious cardiac arrhythmia No New York Heart Association class III or IV heart disease No history of cardiac toxicities with prior fluorouracil and leucovorin calcium No myocardial infarction within the past 6 months Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No known dihydropyrimidine dehydrogenase deficiency No allergy to platinum-containing drugs No history of intolerance to study anti-emetics (e.g., 5-HT3 antagonists) No known peripheral neuropathy (absence of deep tendon reflexes as sole deficiency allowed) No uncontrolled diabetes No active infection No other active malignancy originating from primary site other than colon or rectum

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics One and only 1 prior chemotherapy regimen for metastatic disease consisting of first-line irinotecan, fluorouracil, and leucovorin calcium (Saltz regimen) Prior adjuvant fluorouracil with leucovorin calcium allowed At least 3 weeks since prior chemotherapy for metastatic disease and recovered No prior adjuvant irinotecan No prior oxaliplatin Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to study lesions unless evidence of progressive disease within the radiotherapy port At least 3 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered Prior surgical resection of primary tumor or metastases allowed Other: At least 30 days since prior investigational drugs No other concurrent investigational agents No other concurrent anti-cancer therapy No concurrent participation in other investigational trials


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00008281


Locations
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United States, Alabama
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States, 35801
Oncology Center at Providence Park
Mobile, Alabama, United States, 36608
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, Arkansas
Arkansas Oncology Associates, P.A.
Little Rock, Arkansas, United States, 72207
United States, California
Offices of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee
Arcadia, California, United States, 91007-7678
California Cancer Care, Inc.
Greenbrae, California, United States, 94904
Medical Oncology Internal Medicine
Los Angeles, California, United States, 90067
Bay Area Tumor Institute
Oakland, California, United States, 94609
Medical Oncology Care Associates
Orange, California, United States, 92668
P.M.K. Medical Group, Inc.
Oxnard, California, United States, 93030
Cancer and Blood Institute of the Desert
Rancho Mirage, California, United States, 92270
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States, 92120
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States, 94589
United States, Colorado
Kaiser Permanente - Denver
Denver, Colorado, United States, 80205
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Connecticut
Northwestern Connecticut Oncology-Hematology Associates
Torrington, Connecticut, United States, 06790
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, United States, 33428
Center for Hematology-Oncology
Boca Raton, Florida, United States, 33486
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0296
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, United States, 33021
Florida Community Cancer Center
Hudson, Florida, United States, 34667
North Florida Hematology & Oncology Associates
Jacksonville, Florida, United States, 32204
Hematology/Oncology Associates
Jacksonville, Florida, United States, 32216
Lakeland Regional Medical Center
Lakeland, Florida, United States, 33804
Mount Sinai Comprehensive Cancer Center
Miami, Florida, United States, 33140
Oncology-Hematology Group of South Florida
Miami, Florida, United States, 33176
Ocala Oncology Center
Ocala, Florida, United States, 34474
Office of Thomas A. Marsland
Orange Park, Florida, United States, 32073
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Office of Barry S. Berman
Orlando, Florida, United States, 32806
Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
Hematology-Oncology Associates, PA
Pensacola, Florida, United States, 32501
Hematology/Oncology Associates
Port Saint Lucie, Florida, United States, 34952
Oncology & Hematology Associates of West Broward
Tamarac, Florida, United States, 33321
Office of Ron D. Schiff
Tampa, Florida, United States, 33613
Hematology and Oncology Consultants
Titusville, Florida, United States, 32796
United States, Illinois
Dreyer Medical Clinic
Aurora, Illinois, United States, 60506
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States, 60035
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
United States, Indiana
Oncology and Hematology Associates
Greenfield, Indiana, United States, 46140
Cancer Care Center
New Albany, Indiana, United States, 47150
United States, Iowa
Oncology Associates of Cedar Rapids
Cedar Rapids, Iowa, United States, 52403
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States, 67214
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Louisiana
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70821-2511
Louisiana Oncology Associates
Lafayette, Louisiana, United States, 70506
Physicians Office
Metairie, Louisiana, United States, 70006
Louisiana State University School of Medicine
New Orleans, Louisiana, United States, 70112-2822
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States, 04074
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Parker Hughes Cancer Center
Roseville, Minnesota, United States, 55113
Park Nicollet Clinic
St. Louis Park, Minnesota, United States, 55416
United States, Missouri
Columbia Comprehensive Cancer Care Clinic
Columbia, Missouri, United States, 65201
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
Midwest Oncology Consortium
Kansas City, Missouri, United States, 64111
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
St. John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Missouri Cancer Care, P.C.
St. Charles, Missouri, United States, 63301
United States, New Jersey
Cooper Hospital/University Medical Center
Voorhees, New Jersey, United States, 08043
United States, New York
Veterans Affairs Medical Center - Albany
Albany, New York, United States, 12208
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, United States, 11733
Capitol District Hematology Oncology Associates, P.C.
Latham, New York, United States, 12110-0610
St. Vincents Comprehensive Cancer Center
New York, New York, United States, 10011
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Interlakes Oncology/Hematology PC
Rochester, New York, United States, 14623
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-7775
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Regional Hematology Oncology Associates
Durham, North Carolina, United States, 27704
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, United States, 27609
Piedmont Hematology-Oncology Associates-Triad
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Hematology Oncology Consultants Inc
Columbus, Ohio, United States, 43235
Dayton Oncology/Hematology P.A.
Dayton, Ohio, United States, 45439
United States, Oklahoma
Naz Medical Center
Midwest City, Oklahoma, United States, 73310
Cancer Care Associates
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401-8122
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Oncology/Hematology Associates - Beaver
Beaver, Pennsylvania, United States, 15009
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Tennessee
Erlanger Health Systems
Chattanooga, Tennessee, United States, 37403
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States, 37901
West Clinic, P.C.
Memphis, Tennessee, United States, 38117
Memphis Cancer Center
Memphis, Tennessee, United States, 38119
St. Thomas Medical Center
Nashville, Tennessee, United States, 37205
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Lone Star Oncology
Austin, Texas, United States, 78759
Texas Oncology P.A.
Dallas, Texas, United States, 75230-2503
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, United States, 75230
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Texas Cancer Center Southwest
Dallas, Texas, United States, 75235
Texas Oncology PA (TOPA) at Baylor-Sammons
Dallas, Texas, United States, 75246
Texas Oncology, P.A.
Fort Worth, Texas, United States, 76104
Texas Oncology, P.A.
Garland, Texas, United States, 75042
South Texas Regional Cancer Centers - McAllen
McAllen, Texas, United States, 78503
Texas Oncology - Mesquite
Mesqutie, Texas, United States, 75150
Baptist Health System Cancer Program
San Antonio, Texas, United States, 78205
San Antonio Tumor and Blood Clinic
San Antonio, Texas, United States, 78217
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
Hematology-Oncology Associates of Frederiksburg, Inc.
Fredericksburg, Virginia, United States, 22401
Virginia Oncology Associates - Newport News
Newport News, Virginia, United States, 23606
Hematology & Oncology Associates of Virginia
Richmond, Virginia, United States, 23226
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Swedish Medical Center
Seattle, Washington, United States, 98122-4307
Cancer Care Northwest
Spokane, Washington, United States, 99202
Northwest Cancer Specialists
Vancouver, Washington, United States, 98664
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Advanced Health Care
Milwaukee, Wisconsin, United States, 53209
UW Cancer Center Wausau Hospital
Wausau, Wisconsin, United States, 54401
United States, Wyoming
Ivinson Memorial Hospital
Laramie, Wyoming, United States, 82070
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
University of Alberta
Edmonton, Alberta, Canada, T6G 2R7
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Belleville General Hospital
Belleville, Ontario, Canada, K8N 5K5
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Peterborough Oncology Clinic
Peterborough, Ontario, Canada, K9H 7B6
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada, M5G 1X5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Notre Dame Hospital
Montreal, Quebec, Canada, H4L 2M1
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, Canada, G5L 5T1
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Sanofi
Investigators
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Study Chair: Mace L. Rothenberg, MD, FACP Vanderbilt-Ingram Cancer Center

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ClinicalTrials.gov Identifier: NCT00008281    
Other Study ID Numbers: CDR0000068394
SANOFI-EFC4584
BRCC-00036
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: April 2002
Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Oxaliplatin
Fluorouracil
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors