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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00016198

Public ClinicalTrials.gov record NCT00016198. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 5, 2026, 12:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00016198
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Prologue Research International
Industry
Enrollment
Not listed

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2001 (Type not available)
Primary completion
Apr 2003 (Actual)
Completion
Dec 2010 (Actual)
Last update posted
Jun 26, 2013

2001 – 2010

United States locations

U.S. sites
74
U.S. states
29
U.S. cities
69
Facility City State ZIP Site status
Arizona Clinical Research Center Tucson Arizona 85712 —
Arkansas Cancer Clinic, P.A. Pine Bluff Arkansas 71603 —
Citrus Valley Medical Center Covina California 92807 —
Cancer Center and Beckman Research Institute, City of Hope Duarte California 91010-3000 —
California Cancer Care, Inc. Greenbrae California 94904 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
Kenmar Research Institute Los Angeles California 90057 —
Comprehensive Cancer Centers of the Desert Palm Springs California 92262 —
Kaiser Permanente-Southern California Permanente Medical Group San Diego California 92120 —
Kaiser Permanente Medical Center - Vallejo Vallejo California 94589 —
John Muir Medical Center Walnut Creek California 94598 —
Rocky Mountain Cancer Center Denver Colorado 80218 —
Northwestern Connecticut Oncology-Hematology Associates Torrington Connecticut 06790 —
Lombardi Cancer Center Washington D.C. District of Columbia 20007 —
Center for Hematology-Oncology Boca Raton Florida 33486 —
Halifax Medical Center Daytona Beach Florida 32114 —
Florida Cancer Specialists Fort Myers Florida 33901 —
Hematology/Oncology Associates Jacksonville Florida 32216 —
Lake Heart and Cancer Medical Center Leesburg Florida 34748 —
Oncology-Hematology Group of South Florida Miami Florida 33176 —
Florida Hospital Cancer Institute Orlando Florida 32804 —
Hematology/Oncology Associates Port Saint Lucie Florida 34952 —
Northwest Medical Specialists, P.C. Arlington Heights Illinois 60004 —
Dreyer Medical Clinic Aurora Illinois 60506 —
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois 60611-3013 —
Cancer Care Specialists of Central Illinois, S.C. Decatur Illinois 62526 —
Hope Center Terre Haute Indiana 47809 —
Medical Oncology and Hematology Associates Des Moines Iowa 50309 —
Mercy Cancer Center Mason City Iowa 50401 —
Lucille Parker Markey Cancer Center, University of Kentucky Lexington Kentucky 40536-0093 —
James Graham Brown Cancer Center Louisville Kentucky 40202 —
Baton Rouge General Medical Center Baton Rouge Louisiana 70821-2511 —
Cancer and Blood Institute Metairie Louisiana 70006 —
Saints Memorial Medical Center Lowell Massachusetts 01852 —
Saint Joseph Mercy Hospital Ann Arbor Michigan 48106 —
Medical Oncology Group Gulfport Mississippi 39501 —
Jackson Oncology Associates, PLLC Jackson Mississippi 39202 —
St. Joseph Oncology, Inc. Saint Joseph Missouri 64506 —
Deaconess Billings Clinic Billings Montana 59107-5100 —
Monmouth Medical Center Long Branch New Jersey 07740-6395 —
Jersey Shore Cancer Center Neptune City New Jersey 07753 —
Central Jersey Oncology Center New Brunswick New Jersey 08901 —
Hematology Associates of New Jersey, P.A. Ridgewood New Jersey 07450 —
Monmouth Hematology-Oncology Associates, P.A. West Long Branch New Jersey 07764 —
University of New Mexico Cancer Research & Treatment Center Albuquerque New Mexico 87131 —
HemOnCare, P.C. Brooklyn New York 11235 —
North Shore Hematology/Oncology Associates, P.C. East Setauket New York 11733 —
Reddy Cancer Treatment Center Malone New York 12953 —
New York University Medical Center New York New York 10016 —
Memorial Sloan-Kettering Cancer Center New York New York 10021 —
Interlakes Oncology/Hematology PC Rochester New York 14623 —
University of Rochester Medical Center Rochester New York 14642 —
South Shore Hematology Oncology Associates, P.C. Rockville Centre New York 11570 —
Albert Einstein Comprehensive Cancer Center The Bronx New York 10461 —
New York Medical College Valhalla New York 10595 —
Mid-Ohio Oncology/Hematology, Inc. Columbus Ohio 43213 —
Hematology Oncology Consultants Inc Columbus Ohio 43235 —
Lawrence M. Stallings Medical Practice Wooster Ohio 44691 —
Oklahoma Oncology Inc. Tulsa Oklahoma 74104 —
Bend Memorial Clinic Bend Oregon 97701 —
Salem Hospital Regional Cancer Center Salem Oregon 97309-5014 —
Oncology Hematology of Lehigh Valley, P.C. Bethlehem Pennsylvania 18015 —
Pennsylvania Oncology Hematology Associates Philadelphia Pennsylvania 19107 —
Lifespan: The Miriam Hospital Providence Rhode Island 02906 —
Memorial Hospital Cancer Center - Chattanooga Chattanooga Tennessee 37404 —
Family Cancer Center Collierville Tennessee 38017 —
Baptist Regional Cancer Center Knoxville Tennessee 37920 —
West Cancer Clinic Memphis Tennessee 38120 —
Center for Oncology Research and Treatment, Medical City Hospital Dallas Texas 75230 —
Cancer Therapy and Research Center San Antonio Texas 78229 —
Scott and White Memorial Hospital Temple Texas 76508 —
Huntsman Cancer Institute Salt Lake City Utah 84112 —
Intermountain Hematology/Oncology Associates, Inc. Salt Lake City Utah 84124 —
Seattle Cancer Care Alliance Seattle Washington 98109 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00016198, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 26, 2013 · Synced Oct 5, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00016198 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →