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

June 25, 2013 updated by: Prologue Research International

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center
    • Arkansas
      • Pine Bluff, Arkansas, United States, 71603
        • Arkansas Cancer Clinic, P.A.
    • California
      • Covina, California, United States, 92807
        • Citrus Valley Medical Center
      • Duarte, California, United States, 91010-3000
        • Cancer Center and Beckman Research Institute, City of Hope
      • Greenbrae, California, United States, 94904
        • California Cancer Care, Inc.
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90057
        • Kenmar Research Institute
      • Palm Springs, California, United States, 92262
        • Comprehensive Cancer Centers of the Desert
      • San Diego, California, United States, 92120
        • Kaiser Permanente-Southern California Permanente Medical Group
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center - Vallejo
      • Walnut Creek, California, United States, 94598
        • John Muir Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Connecticut
      • Torrington, Connecticut, United States, 06790
        • Northwestern Connecticut Oncology-Hematology Associates
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Lombardi Cancer Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Center for Hematology-Oncology
      • Daytona Beach, Florida, United States, 32114
        • Halifax Medical Center
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists
      • Jacksonville, Florida, United States, 32216
        • Hematology/Oncology Associates
      • Leesburg, Florida, United States, 34748
        • Lake Heart and Cancer Medical Center
      • Miami, Florida, United States, 33176
        • Oncology-Hematology Group of South Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • Port Saint Lucie, Florida, United States, 34952
        • Hematology/Oncology Associates
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • Northwest Medical Specialists, P.C.
      • Aurora, Illinois, United States, 60506
        • Dreyer Medical Clinic
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Central Illinois, S.C.
    • Indiana
      • Terre Haute, Indiana, United States, 47809
        • Hope Center
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates
      • Mason City, Iowa, United States, 50401
        • Mercy Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0093
        • Lucille Parker Markey Cancer Center, University of Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70821-2511
        • Baton Rouge General Medical Center
      • Metairie, Louisiana, United States, 70006
        • Cancer and Blood Institute
    • Massachusetts
      • Lowell, Massachusetts, United States, 01852
        • Saints Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Saint Joseph Mercy Hospital
    • Mississippi
      • Gulfport, Mississippi, United States, 39501
        • Medical Oncology Group
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates, PLLC
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • St. Joseph Oncology, Inc.
    • Montana
      • Billings, Montana, United States, 59107-5100
        • Deaconess Billings Clinic
    • New Jersey
      • Long Branch, New Jersey, United States, 07740-6395
        • Monmouth Medical Center
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore Cancer Center
      • New Brunswick, New Jersey, United States, 08901
        • Central Jersey Oncology Center
      • Ridgewood, New Jersey, United States, 07450
        • Hematology Associates of New Jersey, P.A.
      • West Long Branch, New Jersey, United States, 07764
        • Monmouth Hematology-Oncology Associates, P.A.
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Cancer Research & Treatment Center
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Comprehensive Cancer Center
      • Brooklyn, New York, United States, 11235
        • HemOnCare, P.C.
      • East Setauket, New York, United States, 11733
        • North Shore Hematology/Oncology Associates, P.C.
      • Malone, New York, United States, 12953
        • Reddy Cancer Treatment Center
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10016
        • New York University Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Rochester, New York, United States, 14623
        • Interlakes Oncology/Hematology PC
      • Rockville Centre, New York, United States, 11570
        • South Shore Hematology Oncology Associates, P.C.
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Hematology Oncology Consultants Inc
      • Columbus, Ohio, United States, 43213
        • Mid-Ohio Oncology/Hematology, Inc.
      • Wooster, Ohio, United States, 44691
        • Lawrence M. Stallings Medical Practice
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Oncology Inc.
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Memorial Clinic
      • Salem, Oregon, United States, 97309-5014
        • Salem Hospital Regional Cancer Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Oncology Hematology of Lehigh Valley, P.C.
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Oncology Hematology Associates
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Lifespan: The Miriam Hospital
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Memorial Hospital Cancer Center - Chattanooga
      • Collierville, Tennessee, United States, 38017
        • Family Cancer Center
      • Knoxville, Tennessee, United States, 37920
        • Baptist Regional Cancer Center
      • Memphis, Tennessee, United States, 38120
        • West Cancer Clinic
    • Texas
      • Dallas, Texas, United States, 75230
        • Center for Oncology Research and Treatment, Medical City Hospital
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy and Research Center
      • Temple, Texas, United States, 76508
        • Scott and White Memorial Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
      • Salt Lake City, Utah, United States, 84124
        • Intermountain Hematology/Oncology Associates, Inc.
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prologue Research International

Investigators

  • Study Chair: Richard A. Gams, MD, Prologue Research International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

April 1, 2003

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 6, 2001

First Submitted That Met QC Criteria

January 6, 2004

First Posted (Estimate)

January 7, 2004

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROLOGUE-EFC4760
  • CDR0000068606 (Registry Identifier: PDQ (Physician Data Query))
  • SANOFI-EFC4760

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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