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

18. december 2013 opdateret af: Sanofi

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.

Studieoversigt

Status

Afsluttet

Betingelser

Kolorektal cancer

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Maskning: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Efterforskere

Studiestol: Daniel G. Haller, MD, Abramson Cancer Center of the University of Pennsylvania

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2000

Studieafslutning (Faktiske)

1. oktober 2008

Datoer for studieregistrering

Først indsendt

3. marts 2001

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. december 2013

Sidst verificeret

1. oktober 2002

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CDR0000068524
SANOFI-EFC4585

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .