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

January 3, 2014 updated by: Sanofi

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

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

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Sanofi

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

October 1, 2000

Study Registration Dates

First Submitted

January 6, 2001

First Submitted That Met QC Criteria

February 13, 2004

First Posted (Estimate)

February 16, 2004

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

April 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068394
  • SANOFI-EFC4584
  • BRCC-00036

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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