Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent 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. Identifier: NCT00016198
Recruitment Status : Completed
First Posted : January 7, 2004
Last Update Posted : June 26, 2013
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. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combining fluorouracil and leucovorin with or without oxaliplatin in treating patients who have recurrent metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Phase 2

Detailed Description:

OBJECTIVES: I. Compare the overall response rate and overall survival of patients with recurrent metastatic colorectal adenocarcinoma treated with third-line therapy comprising fluorouracil and leucovorin calcium with or without oxaliplatin. II. Compare the onset and duration of complete and partial responses and duration of disease stabilization in patients treated with these regimens. III. Compare the proportion of patients with stable disease and proportion of patients with tumor-related symptomatic improvement treated with these regimens. IV. Compare the time to disease progression and time to tumor-related symptomatic worsening in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on day 1. On day 2, patients receive leucovorin calcium and fluorouracil as in arm I. Treatment in both arms repeats every 2 weeks for at least 1 year in the absence of disease progression. Patients are followed at day 30 and then for approximately 6 months.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Phase II Study Of Bolus/Infusion 5-FU/LV (de Gramont Regimen) Versus Oxaliplatin And Bolus/Infusion 5-FU/LV (de Gramont Regimen) As Third-Line Treatment Of Patients With Metastatic Colorectal Carcinoma
Study Start Date : May 2001
Actual Primary Completion Date : April 2003
Actual Study Completion Date : December 2010

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the colon or rectum Metastatic/recurrent disease not amenable to potentially curative therapy (e.g., inoperable metastatic disease) Documented sequential disease progression (by CT scan or MRI) after 2 prior chemotherapy regimens for metastatic/recurrent disease At least 1 unidimensionally measurable lesion At least 20 mm by conventional CT scan or MRI OR At least 10 mm by spiral CT scan Must have received prior fluorouracil (or capecitabine) and leucovorin calcium with or without irinotecan as first-line therapy and irinotecan with or without fluorouracil (or capecitabine) and leucovorin calcium as second-line therapy 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) SGOT and SGPT no greater than 2 times ULN (6 times ULN if documented liver metastases present) Alkaline phosphatase no greater than 2 times ULN (6 times ULN if documented liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV symptomatic congestive heart failure No serious cardiac arrhythmia No unstable angina No myocardial infarction within the past 6 months Pulmonary: No interstitial pneumonia No 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 peripheral neuropathy (absence of deep tendon reflexes as the sole neurologic abnormality allowed) No diabetes or active infection No known dihydropyrimidine dehydrogenase deficiency

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior anticancer biologic therapy Chemotherapy: See Disease Characteristics No prior oxaliplatin No prior adjuvant irinotecan Prior adjuvant fluorouracil and leucovorin calcium allowed At least 3 weeks since prior chemotherapy (e.g., second-line irinotecan with or without fluorouracil (or capecitabine) and leucovorin calcium) for metastatic disease and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to target lesion unless documented progression within the radiation portal Surgery: See Disease Characteristics At least 4 weeks since prior surgery for primary tumor or metastases and recovered Other: No prior investigational anticancer drug No other concurrent investigational agents

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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 identifier (NCT number): NCT00016198

  Hide Study Locations
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, Arkansas
Arkansas Cancer Clinic, P.A.
Pine Bluff, Arkansas, United States, 71603
United States, California
Citrus Valley Medical Center
Covina, California, United States, 92807
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
California Cancer Care, Inc.
Greenbrae, California, United States, 94904
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Kenmar Research Institute
Los Angeles, California, United States, 90057
Comprehensive Cancer Centers of the Desert
Palm Springs, California, United States, 92262
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States, 92120
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States, 94589
John Muir Medical Center
Walnut Creek, California, United States, 94598
United States, Colorado
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
Center for Hematology-Oncology
Boca Raton, Florida, United States, 33486
Halifax Medical Center
Daytona Beach, Florida, United States, 32114
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Hematology/Oncology Associates
Jacksonville, Florida, United States, 32216
Lake Heart and Cancer Medical Center
Leesburg, Florida, United States, 34748
Oncology-Hematology Group of South Florida
Miami, Florida, United States, 33176
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Hematology/Oncology Associates
Port Saint Lucie, Florida, United States, 34952
United States, Illinois
Northwest Medical Specialists, P.C.
Arlington Heights, Illinois, United States, 60004
Dreyer Medical Clinic
Aurora, Illinois, United States, 60506
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States, 62526
United States, Indiana
Hope Center
Terre Haute, Indiana, United States, 47809
United States, Iowa
Medical Oncology and Hematology Associates
Des Moines, Iowa, United States, 50309
Mercy Cancer Center
Mason City, Iowa, United States, 50401
United States, Kentucky
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0093
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
Cancer and Blood Institute
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Saints Memorial Medical Center
Lowell, Massachusetts, United States, 01852
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
United States, Mississippi
Medical Oncology Group
Gulfport, Mississippi, United States, 39501
Jackson Oncology Associates, PLLC
Jackson, Mississippi, United States, 39202
United States, Missouri
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, United States, 64506
United States, Montana
Deaconess Billings Clinic
Billings, Montana, United States, 59107-5100
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Jersey Shore Cancer Center
Neptune, New Jersey, United States, 07753
Central Jersey Oncology Center
New Brunswick, New Jersey, United States, 08901
Hematology Associates of New Jersey, P.A.
Ridgewood, New Jersey, United States, 07450
Monmouth Hematology-Oncology Associates, P.A.
West Long Branch, New Jersey, United States, 07764
United States, New Mexico
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
HemOnCare, P.C.
Brooklyn, New York, United States, 11235
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, United States, 11733
Reddy Cancer Treatment Center
Malone, New York, United States, 12953
New York University Medical Center
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Interlakes Oncology/Hematology PC
Rochester, New York, United States, 14623
University of Rochester Medical Center
Rochester, New York, United States, 14642
South Shore Hematology Oncology Associates, P.C.
Rockville Centre, New York, United States, 11570
New York Medical College
Valhalla, New York, United States, 10595
United States, Ohio
Mid-Ohio Oncology/Hematology, Inc.
Columbus, Ohio, United States, 43213
Hematology Oncology Consultants Inc
Columbus, Ohio, United States, 43235
Lawrence M. Stallings Medical Practice
Wooster, Ohio, United States, 44691
United States, Oklahoma
Oklahoma Oncology Inc.
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Bend Memorial Clinic
Bend, Oregon, United States, 97701
Salem Hospital Regional Cancer Center
Salem, Oregon, United States, 97309-5014
United States, Pennsylvania
Oncology Hematology of Lehigh Valley, P.C.
Bethlehem, Pennsylvania, United States, 18015
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
Memorial Hospital Cancer Center - Chattanooga
Chattanooga, Tennessee, United States, 37404
Family Cancer Center
Collierville, Tennessee, United States, 38017
Baptist Regional Cancer Center
Knoxville, Tennessee, United States, 37920
West Cancer Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, United States, 75230
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, United States, 84124
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Prologue Research International
Study Chair: Richard A. Gams, MD Prologue Research International Identifier: NCT00016198     History of Changes
Other Study ID Numbers: PROLOGUE-EFC4760
CDR0000068606 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 7, 2004    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: December 2010

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:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents