Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
NCT ID: NCT00012389
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2000-12-31
2008-10-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with or without oxaliplatin in treating patients who have metastatic colorectal cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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irinotecan hydrochloride
oxaliplatin
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Principal Investigators
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Daniel G. Haller, MD
Role: STUDY_CHAIR
Abramson Cancer Center at Penn Medicine
Locations
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Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States
Oncology Center at Providence Park
Mobile, Alabama, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
Citrus Valley Medical Center
Covina, California, United States
California Cancer Care, Inc.
Greenbrae, California, United States
Tower Hematology Oncology Medical Group
Los Angeles, California, United States
Kenmar Research Institute
Los Angeles, California, United States
Los Angeles, California, United States
Medical Oncology Care Associates
Orange, California, United States
P.M.K. Medical Group, Inc.
Oxnard, California, United States
Cancer and Blood Institute of the Desert
Rancho Mirage, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States
John Wayne Cancer Institute
Santa Monica, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
Colorado Permanente Medical Group, P.C.
Denver, Colorado, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Whittingham Cancer Center
Norwalk, Connecticut, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, United States
Center for Hematology-Oncology
Boca Raton, Florida, United States
Southeast Florida Hematology-Oncology Group
Fort Lauderdale, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States
Hematology and Oncology Associates of Jacksonville
Jacksonville, Florida, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
Lake Heart and Cancer Medical Center
Leesburg, Florida, United States
Oncology-Hematology Group of South Florida
Miami, Florida, United States
Hematology and Oncology Consultants, P.A.
Orlando, Florida, United States
Hematology/Oncology Associates
Port Saint Lucie, Florida, United States
Oncology & Hematology Associates of West Broward
Tamarac, Florida, United States
University Community Hospital
Tampa, Florida, United States
Hematology and Oncology Consultants
Titusville, Florida, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
Northwest Medical Specialists, P.C.
Arlington Heights, Illinois, United States
Dreyer Medical Clinic
Aurora, Illinois, United States
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States
Cancer Care Center
New Albany, Indiana, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Kentuckiana Cancer Institute
Louisville, Kentucky, United States
Norton Healthcare Pavilion
Louisville, Kentucky, United States
Veterans Affairs Medical Center - Louisville
Louisville, Kentucky, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Louisiana Oncology Associates
Lafayette, Louisiana, United States
Doctors Hospital of Jefferson
Metairie, Louisiana, United States
Stanley Scott Cancer Center
New Orleans, Louisiana, United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States
Medical Center of Boston
Boston, Massachusetts, United States
Berkshire Hematology Oncology, P.C.
Pittsfield, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Flint, Michigan, United States
Parker Hughes Cancer Center
Roseville, Minnesota, United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States
Missouri Cancer Care, P.C.
Saint Charles, Missouri, United States
Siteman Cancer Center
St Louis, Missouri, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
Great Falls Clinic
Great Falls, Montana, United States
Western Montana Clinic
Missoula, Montana, United States
Somerset Medical Center
Somerville, New Jersey, United States
Cooper Cancer Institute
Voorhees Township, New Jersey, United States
Veterans Affairs Medical Center - Albany
Albany, New York, United States
Queens Medical Associates, PC
Fresh Meadows, New York, United States
Queens Hospital Center
Jamaica, New York, United States
Interlakes Oncology/Hematology PC
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, United States
Piedmont Hematology-Oncology Associates
Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Hematology Oncology Consultants Inc
Columbus, Ohio, United States
Bend Memorial Clinic
Bend, Oregon, United States
Kaiser Permanente - Portland
Portland, Oregon, United States
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, United States
Abington Hematology Oncology Associates, Incorporated
Meadowbrook, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States
Physicians East - Quadrangle
Greenville, South Carolina, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Erlanger Health Systems
Chattanooga, Tennessee, United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States
West Clinic
Memphis, Tennessee, United States
Memphis Cancer Center
Memphis, Tennessee, United States
Tennessee Oncology, P.L.L.C.
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Lone Star Oncology
Austin, Texas, United States
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, United States
Baptist Health System Cancer Program
San Antonio, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Hematology-Oncology Associates of Frederiksburg, Inc.
Fredericksburg, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Advanced Health Care
Milwaukee, Wisconsin, United States
UW Cancer Center Wausau Hospital
Wausau, Wisconsin, United States
Irving Cancer Center
Laramie, Wyoming, United States
Porto Alegre Hospital
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Oncologia de Soracaba
Sorocaba, São Paulo, Brazil
Hospital Joao Alves Fiho
Aracaiu-SE, , Brazil
Hospital Socor
Belo Horizonte-MG, , Brazil
Hospital Erastos Gaertner
Curitiba-PR, , Brazil
Instituto Nacional de Cancer
Rio de Janeiro, , Brazil
Oncologistas Associados
Rio de Janeiro, , Brazil
Hospital do Cancer A C Comargo
São Paulo, , Brazil
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
Cite de la Sante de Laval
Laval, Quebec, Canada
L'Hotel Dieu de Levis
Lévis, Quebec, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Jewish General Hospital - Montreal
Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
Centre Hospitalier de L'Universitaire de Quebec, Pavillon CHUL
Sainte-Foy, Quebec, Canada
L'Hopital Laval
Ste-Foy, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Zoom International Incoporated
Saint Jerome Quebec, , Canada
Centre of Clinical Oncology and Radiation Oncology
České Budějovice, , Czechia
Charles University Hospital
Hradec Králové, , Czechia
Onkologicka Klinka A Onkologicka Lab
Prague, , Czechia
Fakultni Nemocnice V Motole
Prague, , Czechia
Semmelweis University
Budapest, , Hungary
National Institute of Oncology
Budapest, , Hungary
Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia
Budapest, , Hungary
Szent Laszlo Korhaz
Budapest, , Hungary
Kozponti Honvedkorhaz I. Belgyogyaszat
Budapest, , Hungary
Debreceni Egyetem Onkologiai Tanzek
Debrecen, , Hungary
Petz Aladar County Hospital
Gydr, , Hungary
Maria S. Curie Memorial Institute
Gliwice, , Poland
Jagiellonian University
Krakow (Cracow), , Poland
Institute of Oncology
Lodz, , Poland
Wielkopolskie Centrum Onkologii Oddzial Chemioterapii
Poznan, , Poland
St. Luke's Cancer Center
Guildford, England, United Kingdom
St. Bartholomew's Hospital
London, England, United Kingdom
Guy's and St. Thomas' Hospitals NHS Trust
London, England, United Kingdom
Charing Cross Hospital
London, England, United Kingdom
Maidstone Hospital
Maidstone, England, United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Weston Park Hospital
Sheffield, England, United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Countries
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References
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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.
Other Identifiers
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SANOFI-EFC4585
Identifier Type: -
Identifier Source: secondary_id
CDR0000068524
Identifier Type: -
Identifier Source: org_study_id