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Colorectal CancerPhase 3NCT00012389

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

A Phase 3 study testing irinotecan hydrochloride and oxaliplatin in people with Colorectal Cancer, run by Sanofi at 154 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 if irinotecan is more effective with or without oxaliplatin in treating 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?
irinotecan hydrochloride and oxaliplatin
How many people
Not given
Where
154 sitesin 7 countries
Study dates
Dec 2000to Oct 2008
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 adenocarcinoma of the colon or rectum
  • Metastatic or recurrent disease that is not amenable to potentially curative treatment
  • Progressive or recurrent disease during or after 1, and only 1, regimen of fluorouracil with or without leucovorin calcium or during or within 6 months after adjuvant chemotherapy with fluorouracil and leucovorin calcium

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 50-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT/SGPT 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 5 times ULN if liver metastases present)

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No unstable angina
  • No New York Heart Association class III or IV congestive heart failure
  • No serious cardiac arrhythmia
  • No history of cardiac toxicity from fluorouracil/leucovorin calcium
  • No myocardial infarction within past 6 months

Pulmonary:

  • No interstitial pneumonia or extensive and symptomatic fibrosis of the lung

Other:

  • No uncontrolled predisposing colonic or small bowel disorder
  • No prior chronic enteropathy, chronic diarrhea, or unresolved bowel obstruction/subobstruction
  • No diabetes
  • No active infection
  • No known current peripheral neuropathy
  • No concurrent active cancer except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No intolerance of appropriate antiemetics
  • No history of anaphylaxis or potential intolerance to atropine sulfate or loperamide
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy
  • No prior irinotecan or oxaliplatin
  • No other prior chemotherapy agents except fluorouracil with or without leucovorin calcium as first-line therapy for metastatic disease or in the adjuvant setting

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior radiotherapy to non-target lesions allowed
  • No prior radiotherapy to target lesions unless disease progression is documented within the radiation port
  • At least 3 weeks since prior radiotherapy

Surgery:

  • At least 4 weeks since prior major surgical procedure and recovered
  • Prior surgery for primary tumor or metastasis allowed

Other:

  • At least 30 days since prior investigational drug
  • No concurrent investigational agents

Trial locations and contacts

154 sites in 7 countries.

154 sites in 7 countries

United States100 sites

  • Veterans Affairs Medical Center - Albany

    Albany, New York, 12208

  • Northwest Medical Specialists, P.C.

    Arlington Heights, Illinois, 60004

  • Dreyer Medical Clinic

    Aurora, Illinois, 60506

  • Lone Star Oncology

    Austin, Texas, 78759

  • Greater Baltimore Medical Center and Cancer Center

    Baltimore, Maryland, 21204

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70806

  • Bend Memorial Clinic

    Bend, Oregon, 97701

  • Comprehensive Cancer Care Specialists of Boca Raton

    Boca Raton, Florida, 33428

  • Center for Hematology-Oncology

    Boca Raton, Florida, 33486

  • Medical Center of Boston

    Boston, Massachusetts, 02120

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • Erlanger Health Systems

    Chattanooga, Tennessee, 37403

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho, 83814

  • Hematology Oncology Consultants Inc

    Columbus, Ohio, 43235

  • Citrus Valley Medical Center

    Covina, California, 91722

  • Center for Oncology Research and Treatment, Medical City Hospital

    Dallas, Texas, 75230

  • Colorado Permanente Medical Group, P.C.

    Denver, Colorado, 80205

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • University of Colorado Cancer Center

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Study site

    Flint, Michigan, 48532

  • Southeast Florida Hematology-Oncology Group

    Fort Lauderdale, Florida, 33308

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Hematology-Oncology Associates of Frederiksburg, Inc.

    Fredericksburg, Virginia, 22401

  • Queens Medical Associates, PC

    Fresh Meadows, New York, 11365

  • Shands Hospital and Clinics, University of Florida

    Gainesville, Florida, 32610-100277

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • California Cancer Care, Inc.

    Greenbrae, California, 94904-2007

  • Physicians East - Quadrangle

    Greenville, South Carolina, 27834

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29615

  • Pinnacle Health Hospitals

    Harrisburg, Pennsylvania, 17105-8700

  • Comprehensive Cancer Institute of Huntsville

    Huntsville, Alabama, 35801

  • Jackson Oncology Associates, PLLC

    Jackson, Mississippi, 39202

  • Hematology and Oncology Associates of Jacksonville

    Jacksonville, Florida, 32207

  • University of Florida Health Science Center - Jacksonville

    Jacksonville, Florida, 32209

  • Queens Hospital Center

    Jamaica, New York, 11432

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • Baptist Regional Cancer Center - Knoxville

    Knoxville, Tennessee, 37901

  • Louisiana Oncology Associates

    Lafayette, Louisiana, 70506

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33804

  • Irving Cancer Center

    Laramie, Wyoming, 82070

  • Lake Heart and Cancer Medical Center

    Leesburg, Florida, 34748

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • Tower Hematology Oncology Medical Group

    Los Angeles, California, 90048

  • Kenmar Research Institute

    Los Angeles, California, 90057

  • Study site

    Los Angeles, California, 90067

  • 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

  • Abington Hematology Oncology Associates, Incorporated

    Meadowbrook, Pennsylvania, 18974

  • West Clinic

    Memphis, Tennessee, 38117

  • Memphis Cancer Center

    Memphis, Tennessee, 38119

  • Doctors Hospital of Jefferson

    Metairie, Louisiana, 70006

  • Oncology-Hematology Group of South Florida

    Miami, Florida, 33176

  • Advanced Health Care

    Milwaukee, Wisconsin, 53209

  • Western Montana Clinic

    Missoula, Montana, 59807-7609

  • Oncology Center at Providence Park

    Mobile, Alabama, 36688

  • Tennessee Oncology, P.L.L.C.

    Nashville, Tennessee, 37205

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6307

  • Cancer Care Center

    New Albany, Indiana, 47150

  • Stanley Scott Cancer Center

    New Orleans, Louisiana, 70112

  • Whittingham Cancer Center

    Norwalk, Connecticut, 06856

  • Medical Oncology Care Associates

    Orange, California, 92868

  • Hematology and Oncology Consultants, P.A.

    Orlando, Florida, 32804

  • P.M.K. Medical Group, Inc.

    Oxnard, California, 93030

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Oncology Hematology Associates

    Philadelphia, Pennsylvania, 19106

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • Berkshire Hematology Oncology, P.C.

    Pittsfield, Massachusetts, 01201

  • Hematology/Oncology Associates

    Port Saint Lucie, Florida, 34952

  • Kaiser Permanente - Portland

    Portland, Oregon, 97227

  • Lifespan: The Miriam Hospital

    Providence, Rhode Island, 02906

  • Raleigh Hematology/Oncology Associates - Wake Practice

    Raleigh, North Carolina, 27609

  • Cancer and Blood Institute of the Desert

    Rancho Mirage, California, 92270

  • Interlakes Oncology/Hematology PC

    Rochester, New York, 14623

  • Parker Hughes Cancer Center

    Roseville, Minnesota, 55113

  • Missouri Cancer Care, P.C.

    Saint Charles, Missouri, 63301

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Baptist Health System Cancer Program

    San Antonio, Texas, 78205

  • Kaiser Permanente-Southern California Permanente Medical Group

    San Diego, California, 92120

  • John Wayne Cancer Institute

    Santa Monica, California, 90404

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Somerset Medical Center

    Somerville, New Jersey, 08876

  • Siteman Cancer Center

    St Louis, Missouri, 63110

  • St. John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Oncology & Hematology Associates of West Broward

    Tamarac, Florida, 33321

  • University Community Hospital

    Tampa, Florida, 33613

  • Montefiore Medical Center

    The Bronx, New York, 10467-2490

  • Hematology and Oncology Consultants

    Titusville, Florida, 32796

  • Arizona Clinical Research Center

    Tucson, Arizona, 85712

  • New York Medical College

    Valhalla, New York, 10595

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, 94589

  • Cooper Cancer Institute

    Voorhees Township, New Jersey, 08043

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • UW Cancer Center Wausau Hospital

    Wausau, Wisconsin, 54401

  • Piedmont Hematology-Oncology Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada21 sites

  • Royal Victoria Hospital, Barrie

    Barrie, Ontario, L4M 6M2

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • University of Alberta

    Edmonton, Alberta, T6G 2R7

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cite de la Sante de Laval

    Laval, Quebec, H7M 3L9

  • L'Hotel Dieu de Levis

    Lévis, Quebec, G6V 3Z1

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Jewish General Hospital - Montreal

    Montreal, Quebec, H3T 1E2

  • Hopital Du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Zoom International Incoporated

    Saint Jerome Quebec, JYZ 5T3

  • Centre Hospitalier de L'Universitaire de Quebec, Pavillon CHUL

    Sainte-Foy, Quebec, GIV 4G2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • L'Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

United Kingdom10 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • St. Luke's Cancer Center

    Guildford, England, GU2 5XX

  • St. Bartholomew's Hospital

    London, England, EC1A 7BE

  • Guy's and St. Thomas' Hospitals NHS Trust

    London, England, SE1 9RT

  • Charing Cross Hospital

    London, England, W6 8RF

  • Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Christie Hospital N.H.S. Trust

    Manchester, England, M20 4BX

  • Derriford Hospital

    Plymouth, England, PL6 8DH

  • Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Royal Marsden Hospital

    Sutton, England, SM2 5PT

Other trials in United Kingdom

Brazil8 sites

  • Hospital Joao Alves Fiho

    Aracaiu-SE, CEP: 49094-970

  • Hospital Socor

    Belo Horizonte-MG, CEP: 30180-060

  • Hospital Erastos Gaertner

    Curitiba-PR, CEP: 81520-060

  • Porto Alegre Hospital

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Instituto Nacional de Cancer

    Rio de Janeiro, 20230-130

  • Oncologistas Associados

    Rio de Janeiro, CEP: 22260-020

  • Hospital do Cancer A C Comargo

    São Paulo, CEP: 01509-010

  • Instituto de Oncologia de Soracaba

    Sorocaba, São Paulo, 18030-200

Other trials in Brazil

Hungary7 sites

  • Semmelweis University

    Budapest, 1082

  • National Institute of Oncology

    Budapest, 1125

  • Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia

    Budapest, H-1032

  • Szent Laszlo Korhaz

    Budapest, H-1097

  • Kozponti Honvedkorhaz I. Belgyogyaszat

    Budapest, H-1134

  • Debreceni Egyetem Onkologiai Tanzek

    Debrecen, H-4012

  • Petz Aladar County Hospital

    Gydr, h-9024

Other trials in Hungary

Czechia4 sites

  • Centre of Clinical Oncology and Radiation Oncology

    České Budějovice, 370 01

  • Charles University Hospital

    Hradec Králové, 500 02

  • Onkologicka Klinka A Onkologicka Lab

    Prague, 128 08

  • Fakultni Nemocnice V Motole

    Prague, 150 06

Other trials in Czechia

Poland4 sites

  • Maria S. Curie Memorial Institute

    Gliwice, 44-101

  • Jagiellonian University

    Krakow (Cracow), 31-826

  • Institute of Oncology

    Lodz, 93509

  • Wielkopolskie Centrum Onkologii Oddzial Chemioterapii

    Poznan, 61-866

Other trials in Poland

About this study

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

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.

Read the detailed description

OBJECTIVES:

  • Compare the overall survival of patients with metastatic colorectal cancer treated with irinotecan with or without oxaliplatin.
  • Compare the response rate, time to tumor-related worsening of symptoms, time to disease progression, onset and duration of responses, and duration of disease stabilization in these patients treated with these regimens.
  • Compare the safety 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 involved (1 vs 2 or more), lactic dehydrogenase (no greater than 1.5 times upper limit of normal (ULN) vs greater than 1.5 times ULN), and prior fluorouracil chemotherapy (adjuvant vs first-line treatment for metastatic disease). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive irinotecan IV over 90 minutes on day 1.
  • Arm II: Patients receive oxaliplatin IV over 120 minutes followed by irinotecan IV over 30 minutes on day 1.

Courses repeat in each arm every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days, every 4 weeks for 3 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 596 patients (298 per arm) will be accrued for this study within 18 months.

Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
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 posted27 Jan 2003 (estimated)
  2. Study startDec 2000
  3. Study completionOct 2008

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
Allocation
Randomised
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00012389
Sponsor's protocol ID
CDR0000068524
Other IDs
SANOFI-EFC4585
Status last verified
Oct 2002
First submitted
3 Mar 2001
Last updated
19 Dec 2013
Results posted
No

Publications

  • Haller DG, Rothenberg ML, Wong AO, Koralewski PM, Miller WH Jr, Bodoky G, Habboubi N, Garay C, Olivatto LO. Oxaliplatin plus irinotecan compared with irinotecan alone as second-line treatment after single-agent fluoropyrimidine therapy for metastatic colorectal carcinoma. J Clin Oncol. 2008 Oct 1;26(28):4544-50. doi: 10.1200/JCO.2008.17.1249.

    PubMed 18824706

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing irinotecan hydrochloride and oxaliplatin in people with Colorectal Cancer, run by Sanofi at 154 sites in 7 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: finished, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States, Canada, United Kingdom, Brazil, Hungary and 2 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 NCT00012389, which also lists 1 linked publication.

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 19 Dec 2013.

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