Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer

Last updated: June 25, 2013
Sponsor: Prologue Research International
Overall Status: Completed

Phase

2

Condition

Colorectal Cancer

Rectal Cancer

Colon Cancer

Treatment

N/A

Clinical Study ID

NCT00016198
PROLOGUE-EFC4760
CDR0000068606
SANOFI-EFC4760
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Study Start date:
May 01, 2001
Estimated Completion Date:
December 31, 2010

Study 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.

Connect with a study center

  • Arizona Clinical Research Center

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Arkansas Cancer Clinic, P.A.

    Pine Bluff, Arkansas 71603
    United States

    Site Not Available

  • Citrus Valley Medical Center

    Covina, California 92807
    United States

    Site Not Available

  • Cancer Center and Beckman Research Institute, City of Hope

    Duarte, California 91010-3000
    United States

    Site Not Available

  • California Cancer Care, Inc.

    Greenbrae, California 94904
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Kenmar Research Institute

    Los Angeles, California 90057
    United States

    Site Not Available

  • Comprehensive Cancer Centers of the Desert

    Palm Springs, California 92262
    United States

    Site Not Available

  • Kaiser Permanente-Southern California Permanente Medical Group

    San Diego, California 92120
    United States

    Site Not Available

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California 94589
    United States

    Site Not Available

  • John Muir Medical Center

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Rocky Mountain Cancer Center

    Denver, Colorado 80218
    United States

    Site Not Available

  • Northwestern Connecticut Oncology-Hematology Associates

    Torrington, Connecticut 06790
    United States

    Site Not Available

  • Lombardi Cancer Center

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Center for Hematology-Oncology

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Halifax Medical Center

    Daytona Beach, Florida 32114
    United States

    Site Not Available

  • Florida Cancer Specialists

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Hematology/Oncology Associates

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Lake Heart and Cancer Medical Center

    Leesburg, Florida 34748
    United States

    Site Not Available

  • Oncology-Hematology Group of South Florida

    Miami, Florida 33176
    United States

    Site Not Available

  • Florida Hospital Cancer Institute

    Orlando, Florida 32804
    United States

    Site Not Available

  • Hematology/Oncology Associates

    Port Saint Lucie, Florida 34952
    United States

    Site Not Available

  • Northwest Medical Specialists, P.C.

    Arlington Heights, Illinois 60004
    United States

    Site Not Available

  • Dreyer Medical Clinic

    Aurora, Illinois 60506
    United States

    Site Not Available

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois 60611-3013
    United States

    Site Not Available

  • Cancer Care Specialists of Central Illinois, S.C.

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Hope Center

    Terre Haute, Indiana 47809
    United States

    Site Not Available

  • Medical Oncology and Hematology Associates

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Mercy Cancer Center

    Mason City, Iowa 50401
    United States

    Site Not Available

  • Lucille Parker Markey Cancer Center, University of Kentucky

    Lexington, Kentucky 40536-0093
    United States

    Site Not Available

  • James Graham Brown Cancer Center

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana 70821-2511
    United States

    Site Not Available

  • Cancer and Blood Institute

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Saints Memorial Medical Center

    Lowell, Massachusetts 01852
    United States

    Site Not Available

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Medical Oncology Group

    Gulfport, Mississippi 39501
    United States

    Site Not Available

  • Jackson Oncology Associates, PLLC

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • St. Joseph Oncology, Inc.

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Deaconess Billings Clinic

    Billings, Montana 59107-5100
    United States

    Site Not Available

  • Monmouth Medical Center

    Long Branch, New Jersey 07740-6395
    United States

    Site Not Available

  • Jersey Shore Cancer Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Central Jersey Oncology Center

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Hematology Associates of New Jersey, P.A.

    Ridgewood, New Jersey 07450
    United States

    Site Not Available

  • Monmouth Hematology-Oncology Associates, P.A.

    West Long Branch, New Jersey 07764
    United States

    Site Not Available

  • University of New Mexico Cancer Research & Treatment Center

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Albert Einstein Comprehensive Cancer Center

    Bronx, New York 10461
    United States

    Site Not Available

  • HemOnCare, P.C.

    Brooklyn, New York 11235
    United States

    Site Not Available

  • North Shore Hematology/Oncology Associates, P.C.

    East Setauket, New York 11733
    United States

    Site Not Available

  • Reddy Cancer Treatment Center

    Malone, New York 12953
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • New York University Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • Interlakes Oncology/Hematology PC

    Rochester, New York 14623
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • South Shore Hematology Oncology Associates, P.C.

    Rockville Centre, New York 11570
    United States

    Site Not Available

  • New York Medical College

    Valhalla, New York 10595
    United States

    Site Not Available

  • Hematology Oncology Consultants Inc

    Columbus, Ohio 43235
    United States

    Site Not Available

  • Mid-Ohio Oncology/Hematology, Inc.

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Lawrence M. Stallings Medical Practice

    Wooster, Ohio 44691
    United States

    Site Not Available

  • Oklahoma Oncology Inc.

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Bend Memorial Clinic

    Bend, Oregon 97701
    United States

    Site Not Available

  • Salem Hospital Regional Cancer Center

    Salem, Oregon 97309-5014
    United States

    Site Not Available

  • Oncology Hematology of Lehigh Valley, P.C.

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • Pennsylvania Oncology Hematology Associates

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Lifespan: The Miriam Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Memorial Hospital Cancer Center - Chattanooga

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Family Cancer Center

    Collierville, Tennessee 38017
    United States

    Site Not Available

  • Baptist Regional Cancer Center

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • West Cancer Clinic

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Center for Oncology Research and Treatment, Medical City Hospital

    Dallas, Texas 75230
    United States

    Site Not Available

  • Cancer Therapy and Research Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Scott and White Memorial Hospital

    Temple, Texas 76508
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Intermountain Hematology/Oncology Associates, Inc.

    Salt Lake City, Utah 84124
    United States

    Site Not Available

  • Seattle Cancer Care Alliance

    Seattle, Washington 98109
    United States

    Site Not Available

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