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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00012389
First received: March 3, 2001
Last updated: December 18, 2013
Last verified: October 2002
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: irinotecan hydrochloride
Drug: oxaliplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2000
Study Completion Date: October 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012389

  Hide Study Locations
Locations
United States, Alabama
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States, 35801
Oncology Center at Providence Park
Mobile, Alabama, United States, 36688
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, California
Citrus Valley Medical Center
Covina, California, United States, 91722
California Cancer Care, Inc.
Greenbrae, California, United States, 94904-2007
Los Angeles, California, United States, 90067
Kenmar Research Institute
Los Angeles, California, United States, 90057
Tower Hematology Oncology Medical Group
Los Angeles, California, United States, 90048
Medical Oncology Care Associates
Orange, California, United States, 92868
P.M.K. Medical Group, Inc.
Oxnard, California, United States, 93030
Cancer and Blood Institute of the Desert
Rancho Mirage, California, United States, 92270
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States, 92120
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States, 94589
United States, Colorado
Colorado Permanente Medical Group, P.C.
Denver, Colorado, United States, 80205
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
University of Colorado Cancer Center
Denver, Colorado, United States, 80220
United States, Connecticut
Whittingham Cancer Center
Norwalk, Connecticut, United States, 06856
United States, District of Columbia
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
Center for Hematology-Oncology
Boca Raton, Florida, United States, 33486
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, United States, 33428
Southeast Florida Hematology-Oncology Group
Fort Lauderdale, Florida, United States, 33308
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States, 32610-100277
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, United States, 32209
Hematology and Oncology Associates of Jacksonville
Jacksonville, Florida, United States, 32207
Lakeland Regional Medical Center
Lakeland, Florida, United States, 33804
Lake Heart and Cancer Medical Center
Leesburg, Florida, United States, 34748
Oncology-Hematology Group of South Florida
Miami, Florida, United States, 33176
Hematology and Oncology Consultants, P.A.
Orlando, Florida, United States, 32804
Hematology/Oncology Associates
Port Saint Lucie, Florida, United States, 34952
Oncology & Hematology Associates of West Broward
Tamarac, Florida, United States, 33321
University Community Hospital
Tampa, Florida, United States, 33613
Hematology and Oncology Consultants
Titusville, Florida, United States, 32796
United States, Idaho
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Northwest Medical Specialists, P.C.
Arlington Heights, Illinois, United States, 60004
Dreyer Medical Clinic
Aurora, Illinois, United States, 60506
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
United States, Indiana
Cancer Care Center
New Albany, Indiana, United States, 47150
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Kentuckiana Cancer Institute
Louisville, Kentucky, United States, 40202
Norton Healthcare Pavilion
Louisville, Kentucky, United States, 40202
Veterans Affairs Medical Center - Louisville
Louisville, Kentucky, United States, 40206
United States, Louisiana
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70806
Louisiana Oncology Associates
Lafayette, Louisiana, United States, 70506
Doctors Hospital of Jefferson
Metairie, Louisiana, United States, 70006
Stanley Scott Cancer Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Medical Center of Boston
Boston, Massachusetts, United States, 02120
Berkshire Hematology Oncology, P.C.
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Flint, Michigan, United States, 48532
United States, Minnesota
Parker Hughes Cancer Center
Roseville, Minnesota, United States, 55113
United States, Mississippi
Jackson Oncology Associates, PLLC
Jackson, Mississippi, United States, 39202
United States, Missouri
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
St. John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Missouri Cancer Care, P.C.
St. Charles, Missouri, United States, 63301
United States, Montana
Great Falls Clinic
Great Falls, Montana, United States, 59405
Western Montana Clinic
Missoula, Montana, United States, 59807-7609
United States, New Jersey
Somerset Medical Center
Somerville, New Jersey, United States, 08876
Cooper Cancer Institute
Voorhees, New Jersey, United States, 08043
United States, New York
Veterans Affairs Medical Center - Albany
Albany, New York, United States, 12208
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
Queens Medical Associates, PC
Fresh Meadows, New York, United States, 11365
Queens Hospital Center
Jamaica, New York, United States, 11432
Interlakes Oncology/Hematology PC
Rochester, New York, United States, 14623
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, United States, 27609
Piedmont Hematology-Oncology Associates
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Hematology Oncology Consultants Inc
Columbus, Ohio, United States, 43235
United States, Oregon
Bend Memorial Clinic
Bend, Oregon, United States, 97701
Kaiser Permanente - Portland
Portland, Oregon, United States, 97227
United States, Pennsylvania
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, United States, 17105-8700
Abington Hematology Oncology Associates, Incorporated
Meadowbrook, Pennsylvania, United States, 18974
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29615
Physicians East - Quadrangle
Greenville, South Carolina, United States, 27834
United States, Tennessee
Erlanger Health Systems
Chattanooga, Tennessee, United States, 37403
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States, 37901
Memphis Cancer Center
Memphis, Tennessee, United States, 38119
West Clinic
Memphis, Tennessee, United States, 38117
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6307
Tennessee Oncology, P.L.L.C.
Nashville, Tennessee, United States, 37205
United States, Texas
Lone Star Oncology
Austin, Texas, United States, 78759
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, United States, 75230
Baptist Health System Cancer Program
San Antonio, Texas, United States, 78205
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Hematology-Oncology Associates of Frederiksburg, Inc.
Fredericksburg, Virginia, United States, 22401
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
United States, Wisconsin
Advanced Health Care
Milwaukee, Wisconsin, United States, 53209
UW Cancer Center Wausau Hospital
Wausau, Wisconsin, United States, 54401
United States, Wyoming
Irving Cancer Center
Laramie, Wyoming, United States, 82070
Brazil
Porto Alegre Hospital
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Instituto de Oncologia de Soracaba
Sorocaba, Sao Paulo, Brazil, 18030-200
Hospital Joao Alves Fiho
Aracaiu-SE, Brazil, CEP: 49094-970
Hospital Socor
Belo Horizonte-MG, Brazil, CEP: 30180-060
Hospital Erastos Gaertner
Curitiba-PR, Brazil, CEP: 81520-060
Instituto Nacional de Cancer
Rio de Janeiro, Brazil, 20230-130
Oncologistas Associados
Rio de Janeiro, Brazil, CEP: 22260-020
Hospital do Cancer A C Comargo
Sao Paulo, Brazil, CEP: 01509-010
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
University of Alberta
Edmonton, Alberta, Canada, T6G 2R7
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Royal Victoria Hospital, Barrie
Barrie, Ontario, Canada, L4M 6M2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada, M5G 1X5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Cite de la Sante de Laval
Laval, Quebec, Canada, H7M 3L9
L'Hotel Dieu de Levis
Levis, Quebec, Canada, G6V 3Z1
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Jewish General Hospital - Montreal
Montreal, Quebec, Canada, H3T 1E2
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Centre Hospitalier de L'Universitaire de Quebec, Pavillon CHUL
Sainte Foy, Quebec, Canada, GIV 4G2
L'Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
Zoom International Incoporated
St. Jerome Quebec, Canada, JYZ 5T3
Czech Republic
Centre of Clinical Oncology and Radiation Oncology
Ceske Budejovice, Czech Republic, 370 01
Charles University Hospital
Hradec Kralove, Czech Republic, 500 02
Onkologicka Klinka A Onkologicka Lab
Prague, Czech Republic, 128 08
Fakultni Nemocnice V Motole
Praha, Czech Republic, 150 06
Hungary
Szent Laszlo Korhaz
Budapest, Hungary, H-1097
Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia
Budapest, Hungary, H-1032
Semmelweis University
Budapest, Hungary, 1082
National Institute of Oncology
Budapest, Hungary, 1125
Kozponti Honvedkorhaz I. Belgyogyaszat
Budapest, Hungary, H-1134
Debreceni Egyetem Onkologiai Tanzek
Debrecen, Hungary, H-4012
Petz Aladar County Hospital
Gydr, Hungary, h-9024
Poland
Maria S. Curie Memorial Institute
Gliwice, Poland, 44-101
Jagiellonian University
Krakow (Cracow), Poland, 31-826
Institute of Oncology
Lodz, Poland, 93509
Wielkopolskie Centrum Onkologii Oddzial Chemioterapii
Poznan, Poland, 61-866
United Kingdom
St. Luke's Cancer Center
Guildford, England, United Kingdom, GU2 5XX
St. Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Charing Cross Hospital
London, England, United Kingdom, W6 8RF
Guy's and St. Thomas' Hospitals NHS Trust
London, England, United Kingdom, SE1 9RT
Maidstone Hospital
Maidstone, England, United Kingdom, ME16 9QQ
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH
Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Sponsors and Collaborators
Sanofi
Investigators
Study Chair: Daniel G. Haller, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00012389     History of Changes
Other Study ID Numbers: CDR0000068524, SANOFI-EFC4585
Study First Received: March 3, 2001
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Irinotecan
Camptothecin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014