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Completed Phase 3 Interventional

Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer

ClinicalTrials.gov ID: NCT00012389

Public ClinicalTrials.gov record NCT00012389. 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 11, 2026, 3:10 PM 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 Multicenter, Open-Label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of 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. It is not yet known if irinotecan is more effective with or without oxaliplatin in treating metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with or without oxaliplatin in treating patients who have metastatic colorectal cancer.

Study identification

NCT ID
NCT00012389
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
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
Dec 2000 (Type not available)
Primary completion
Not listed
Completion
Oct 2008 (Actual)
Last update posted
Dec 19, 2013

2000 – 2008

United States locations

U.S. sites
100
U.S. states
34
U.S. cities
86
Facility City State ZIP Site status
Comprehensive Cancer Institute of Huntsville Huntsville Alabama 35801 —
Oncology Center at Providence Park Mobile Alabama 36688 —
Arizona Clinical Research Center Tucson Arizona 85712 —
Citrus Valley Medical Center Covina California 91722 —
California Cancer Care, Inc. Greenbrae California 94904-2007 —
Tower Hematology Oncology Medical Group Los Angeles California 90048 —
Kenmar Research Institute Los Angeles California 90057 —
Not listed Los Angeles California 90067 —
Medical Oncology Care Associates Orange California 92868 —
P.M.K. Medical Group, Inc. Oxnard California 93030 —
Cancer and Blood Institute of the Desert Rancho Mirage California 92270 —
Kaiser Permanente-Southern California Permanente Medical Group San Diego California 92120 —
John Wayne Cancer Institute Santa Monica California 90404 —
Kaiser Permanente Medical Center - Vallejo Vallejo California 94589 —
Colorado Permanente Medical Group, P.C. Denver Colorado 80205 —
Rocky Mountain Cancer Center Denver Colorado 80218 —
University of Colorado Cancer Center Denver Colorado 80220 —
Whittingham Cancer Center Norwalk Connecticut 06856 —
George Washington University Medical Center Washington D.C. District of Columbia 20037 —
Comprehensive Cancer Care Specialists of Boca Raton Boca Raton Florida 33428 —
Center for Hematology-Oncology Boca Raton Florida 33486 —
Southeast Florida Hematology-Oncology Group Fort Lauderdale Florida 33308 —
Florida Cancer Specialists Fort Myers Florida 33901 —
Shands Hospital and Clinics, University of Florida Gainesville Florida 32610-100277 —
Hematology and Oncology Associates of Jacksonville Jacksonville Florida 32207 —
University of Florida Health Science Center - Jacksonville Jacksonville Florida 32209 —
Lakeland Regional Medical Center Lakeland Florida 33804 —
Lake Heart and Cancer Medical Center Leesburg Florida 34748 —
Oncology-Hematology Group of South Florida Miami Florida 33176 —
Hematology and Oncology Consultants, P.A. Orlando Florida 32804 —
Hematology/Oncology Associates Port Saint Lucie Florida 34952 —
Oncology & Hematology Associates of West Broward Tamarac Florida 33321 —
University Community Hospital Tampa Florida 33613 —
Hematology and Oncology Consultants Titusville Florida 32796 —
North Idaho Cancer Center Coeur d'Alene Idaho 83814 —
Northwest Medical Specialists, P.C. Arlington Heights Illinois 60004 —
Dreyer Medical Clinic Aurora Illinois 60506 —
Northwestern Medical Faculty Foundation Chicago Illinois 60611 —
Cancer Care Center New Albany Indiana 47150 —
Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky 40536-0084 —
James Graham Brown Cancer Center Louisville Kentucky 40202 —
Kentuckiana Cancer Institute Louisville Kentucky 40202 —
Norton Healthcare Pavilion Louisville Kentucky 40202 —
Veterans Affairs Medical Center - Louisville Louisville Kentucky 40206 —
Baton Rouge General Medical Center Baton Rouge Louisiana 70806 —
Louisiana Oncology Associates Lafayette Louisiana 70506 —
Doctors Hospital of Jefferson Metairie Louisiana 70006 —
Stanley Scott Cancer Center New Orleans Louisiana 70112 —
Greater Baltimore Medical Center and Cancer Center Baltimore Maryland 21204 —
Medical Center of Boston Boston Massachusetts 02120 —
Berkshire Hematology Oncology, P.C. Pittsfield Massachusetts 01201 —
Barbara Ann Karmanos Cancer Institute Detroit Michigan 48201-1379 —
Not listed Flint Michigan 48532 —
Parker Hughes Cancer Center Roseville Minnesota 55113 —
Jackson Oncology Associates, PLLC Jackson Mississippi 39202 —
Veterans Affairs Medical Center - Kansas City Kansas City Missouri 64128 —
Missouri Cancer Care, P.C. Saint Charles Missouri 63301 —
Siteman Cancer Center St Louis Missouri 63110 —
St. John's Mercy Medical Center St Louis Missouri 63141 —
Great Falls Clinic Great Falls Montana 59405 —
Western Montana Clinic Missoula Montana 59807-7609 —
Somerset Medical Center Somerville New Jersey 08876 —
Cooper Cancer Institute Voorhees Township New Jersey 08043 —
Veterans Affairs Medical Center - Albany Albany New York 12208 —
Queens Medical Associates, PC Fresh Meadows New York 11365 —
Queens Hospital Center Jamaica New York 11432 —
Interlakes Oncology/Hematology PC Rochester New York 14623 —
Montefiore Medical Center The Bronx New York 10467-2490 —
New York Medical College Valhalla New York 10595 —
Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina 27599-7295 —
Raleigh Hematology/Oncology Associates - Wake Practice Raleigh North Carolina 27609 —
Piedmont Hematology-Oncology Associates Winston-Salem North Carolina 27103 —
Cleveland Clinic Taussig Cancer Center Cleveland Ohio 44195 —
Hematology Oncology Consultants Inc Columbus Ohio 43235 —
Bend Memorial Clinic Bend Oregon 97701 —
Kaiser Permanente - Portland Portland Oregon 97227 —
Pinnacle Health Hospitals Harrisburg Pennsylvania 17105-8700 —
Abington Hematology Oncology Associates, Incorporated Meadowbrook Pennsylvania 18974 —
University of Pennsylvania Cancer Center Philadelphia Pennsylvania 19104 —
Pennsylvania Oncology Hematology Associates Philadelphia Pennsylvania 19106 —
University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania 15213 —
Lifespan: The Miriam Hospital Providence Rhode Island 02906 —
Physicians East - Quadrangle Greenville South Carolina 27834 —
Cancer Centers of the Carolinas Greenville South Carolina 29615 —
Erlanger Health Systems Chattanooga Tennessee 37403 —
Baptist Regional Cancer Center - Knoxville Knoxville Tennessee 37901 —
West Clinic Memphis Tennessee 38117 —
Memphis Cancer Center Memphis Tennessee 38119 —
Tennessee Oncology, P.L.L.C. Nashville Tennessee 37205 —
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232-6307 —
Lone Star Oncology Austin Texas 78759 —
Center for Oncology Research and Treatment, Medical City Hospital Dallas Texas 75230 —
Baptist Health System Cancer Program San Antonio Texas 78205 —
Huntsman Cancer Institute Salt Lake City Utah 84112 —
Cancer Center at the University of Virginia Charlottesville Virginia 22908 —
Hematology-Oncology Associates of Frederiksburg, Inc. Fredericksburg Virginia 22401 —
Virginia Mason Medical Center Seattle Washington 98101 —
Advanced Health Care Milwaukee Wisconsin 53209 —
UW Cancer Center Wausau Hospital Wausau Wisconsin 54401 —
Irving Cancer Center Laramie Wyoming 82070 —

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 54 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00012389, 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 Dec 19, 2013 · Synced Oct 11, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00012389 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →