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AzTrials

Colorectal CancerPhase 3NCT00008281

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

A Phase 3 study testing FOLFOX regimen, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by Sanofi at 134 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
FOLFOX regimen, fluorouracil and leucovorin calcium
How many people
Not given
Where
134 sitesin 2 countries
Study dates
Oct 2000to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

134 sites in 2 countries.

134 sites in 2 countries

United States121 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Veterans Affairs Medical Center - Albany

    Albany, New York, 12208

  • Offices of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee

    Arcadia, California, 91007-7678

  • Dreyer Medical Clinic

    Aurora, Illinois, 60506

  • Lone Star Oncology

    Austin, Texas, 78759

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70821-2511

  • Oncology/Hematology Associates - Beaver

    Beaver, Pennsylvania, 15009

  • Comprehensive Cancer Care Specialists of Boca Raton

    Boca Raton, Florida, 33428

  • Center for Hematology-Oncology

    Boca Raton, Florida, 33486

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Oncology Associates of Cedar Rapids

    Cedar Rapids, Iowa, 52403

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Erlanger Health Systems

    Chattanooga, Tennessee, 37403

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611

  • Columbia Comprehensive Cancer Care Clinic

    Columbia, Missouri, 65201

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Hematology Oncology Consultants Inc

    Columbus, Ohio, 43235

  • Texas Oncology P.A.

    Dallas, Texas, 75230-2503

  • Center for Oncology Research and Treatment, Medical City Hospital

    Dallas, Texas, 75230

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Texas Cancer Center Southwest

    Dallas, Texas, 75235

  • Texas Oncology PA (TOPA) at Baylor-Sammons

    Dallas, Texas, 75246

  • Dayton Oncology/Hematology P.A.

    Dayton, Ohio, 45439

  • Kaiser Permanente - Denver

    Denver, Colorado, 80205

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Regional Hematology Oncology Associates

    Durham, North Carolina, 27704

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

    East Setauket, New York, 11733

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401-8122

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • Hematology-Oncology Associates of Frederiksburg, Inc.

    Fredericksburg, Virginia, 22401

  • University of Florida Health Science Center

    Gainesville, Florida, 32610-0296

  • Texas Oncology, P.A.

    Garland, Texas, 75042

  • California Cancer Care, Inc.

    Greenbrae, California, 94904

  • Oncology and Hematology Associates

    Greenfield, Indiana, 46140

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • Hematology Oncology Associates of Illinois-Highland Park

    Highland Park, Illinois, 60035

  • Memorial Regional Hospital Comprehensive Cancer Center

    Hollywood, Florida, 33021

  • Florida Community Cancer Center

    Hudson, Florida, 34667

  • Comprehensive Cancer Institute of Huntsville

    Huntsville, Alabama, 35801

  • North Florida Hematology & Oncology Associates

    Jacksonville, Florida, 32204

  • Hematology/Oncology Associates

    Jacksonville, Florida, 32216

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Midwest Oncology Consortium

    Kansas City, Missouri, 64111

  • Baptist Regional Cancer Center - Knoxville

    Knoxville, Tennessee, 37901

  • Louisiana Oncology Associates

    Lafayette, Louisiana, 70506

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33804

  • Ivinson Memorial Hospital

    Laramie, Wyoming, 82070

  • Capitol District Hematology Oncology Associates, P.C.

    Latham, New York, 12110-0610

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • Arkansas Oncology Associates, P.A.

    Little Rock, Arkansas, 72207

  • Medical Oncology Internal Medicine

    Los Angeles, California, 90067

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • South Texas Regional Cancer Centers - McAllen

    McAllen, Texas, 78503

  • West Clinic, P.C.

    Memphis, Tennessee, 38117

  • Memphis Cancer Center

    Memphis, Tennessee, 38119

  • Texas Oncology - Mesquite

    Mesqutie, Texas, 75150

  • Physicians Office

    Metairie, Louisiana, 70006

  • Mount Sinai Comprehensive Cancer Center

    Miami, Florida, 33140

  • Oncology-Hematology Group of South Florida

    Miami, Florida, 33176

  • Naz Medical Center

    Midwest City, Oklahoma, 73310

  • Advanced Health Care

    Milwaukee, Wisconsin, 53209

  • Oncology Center at Providence Park

    Mobile, Alabama, 36608

  • St. Thomas Medical Center

    Nashville, Tennessee, 37205

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Cancer Care Center

    New Albany, Indiana, 47150

  • Louisiana State University School of Medicine

    New Orleans, Louisiana, 70112-2822

  • St. Vincents Comprehensive Cancer Center

    New York, New York, 10011

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016

  • Virginia Oncology Associates - Newport News

    Newport News, Virginia, 23606

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Medical Oncology Care Associates

    Orange, California, 92668

  • Office of Thomas A. Marsland

    Orange Park, Florida, 32073

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Office of Barry S. Berman

    Orlando, Florida, 32806

  • P.M.K. Medical Group, Inc.

    Oxnard, California, 93030

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068

  • Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Hematology-Oncology Associates, PA

    Pensacola, Florida, 32501

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104-4283

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Pennsylvania Oncology Hematology Associates

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213-3489

  • Hematology/Oncology Associates

    Port Saint Lucie, Florida, 34952

  • Raleigh Hematology/Oncology Associates - Wake Practice

    Raleigh, North Carolina, 27609

  • Cancer and Blood Institute of the Desert

    Rancho Mirage, California, 92270

  • Hematology & Oncology Associates of Virginia

    Richmond, Virginia, 23226

  • Interlakes Oncology/Hematology PC

    Rochester, New York, 14623

  • Parker Hughes Cancer Center

    Roseville, Minnesota, 55113

  • Missouri Cancer Care, P.C.

    Saint Charles, Missouri, 63301

  • Park Nicollet Clinic

    Saint Louis Park, Minnesota, 55416

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Baptist Health System Cancer Program

    San Antonio, Texas, 78205

  • San Antonio Tumor and Blood Clinic

    San Antonio, Texas, 78217

  • Kaiser Permanente-Southern California Permanente Medical Group

    San Diego, California, 92120

  • Maine Center for Cancer Medicine and Blood Disorders

    Scarborough, Maine, 04074

  • Virginia Mason Medical Center

    Seattle, Washington, 98111

  • Swedish Medical Center

    Seattle, Washington, 98122-4307

  • Cancer Care Northwest

    Spokane, Washington, 99202

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • St. John's Mercy Medical Center

    St Louis, Missouri, 63141

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11790-7775

  • Oncology & Hematology Associates of West Broward

    Tamarac, Florida, 33321

  • Office of Ron D. Schiff

    Tampa, Florida, 33613

  • Albert Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

  • Hematology and Oncology Consultants

    Titusville, Florida, 32796

  • Northwestern Connecticut Oncology-Hematology Associates

    Torrington, Connecticut, 06790

  • Arizona Clinical Research Center

    Tucson, Arizona, 85712

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • New York Medical College

    Valhalla, New York, 10595

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, 94589

  • Northwest Cancer Specialists

    Vancouver, Washington, 98664

  • Cooper Hospital/University Medical Center

    Voorhees Township, New Jersey, 08043

  • Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

  • UW Cancer Center Wausau Hospital

    Wausau, Wisconsin, 54401

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Piedmont Hematology-Oncology Associates-Triad

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada13 sites

  • Belleville General Hospital

    Belleville, Ontario, K8N 5K5

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • University of Alberta

    Edmonton, Alberta, T6G 2R7

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Notre Dame Hospital

    Montreal, Quebec, H4L 2M1

  • Peterborough Oncology Clinic

    Peterborough, Ontario, K9H 7B6

  • Centre Hospitalier Regional de Rimouski

    Rimouski, Quebec, G5L 5T1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
FOLFOX regimen, fluorouracil, leucovorin calcium, oxaliplatin
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2004 (estimated)
  2. Study startOct 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00008281
Sponsor's protocol ID
CDR0000068394
Other IDs
SANOFI-EFC4584, BRCC-00036
Status last verified
Apr 2002
First submitted
6 Jan 2001
Last updated
6 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FOLFOX regimen, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by Sanofi at 134 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00008281.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2014; AzTrials last refreshed its copy on 8 Nov 2026.

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