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

18. desember 2013 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Tykktarmskreft

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Brasil
- - Aracaiu-SE, Brasil, CEP: 49094-970
    - Hospital Joao Alves Fiho
  - Belo Horizonte-MG, Brasil, CEP: 30180-060
    - Hospital Socor
  - Curitiba-PR, Brasil, CEP: 81520-060
    - Hospital Erastos Gaertner
  - Rio de Janeiro, Brasil, 20230-130
    - Instituto Nacional de Cancer
  - Rio de Janeiro, Brasil, CEP: 22260-020
    - Oncologistas Associados
  - Sao Paulo, Brasil, CEP: 01509-010
    - Hospital do Cancer A C Comargo
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brasil, 90035-003
    - Porto Alegre Hospital
- Sao Paulo
  - Sorocaba, Sao Paulo, Brasil, 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
    - Hôpital du Sacré-Cœur de Montréal
  - 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
Forente stater
- Alabama
  - Huntsville, Alabama, Forente stater, 35801
    - Comprehensive Cancer Institute of Huntsville
  - Mobile, Alabama, Forente stater, 36688
    - Oncology Center at Providence Park
- Arizona
  - Tucson, Arizona, Forente stater, 85712
    - Arizona Clinical Research Center
- California
  - Covina, California, Forente stater, 91722
    - Citrus Valley Medical Center
  - Greenbrae, California, Forente stater, 94904-2007
    - California Cancer Care, Inc.
  - Los Angeles, California, Forente stater, 90057
    - Kenmar Research Institute
  - Los Angeles, California, Forente stater, 90048
    - Tower Hematology Oncology Medical Group
  - Los Angeles, California, Forente stater, 90067
  - Orange, California, Forente stater, 92868
    - Medical Oncology Care Associates
  - Oxnard, California, Forente stater, 93030
    - P.M.K. Medical Group, Inc.
  - Rancho Mirage, California, Forente stater, 92270
    - Cancer and Blood Institute of the Desert
  - San Diego, California, Forente stater, 92120
    - Kaiser Permanente-Southern California Permanente Medical Group
  - Santa Monica, California, Forente stater, 90404
    - John Wayne Cancer Institute
  - Vallejo, California, Forente stater, 94589
    - Kaiser Permanente Medical Center - Vallejo
- Colorado
  - Denver, Colorado, Forente stater, 80218
    - Rocky Mountain Cancer Center
  - Denver, Colorado, Forente stater, 80205
    - Colorado Permanente Medical Group, P.C.
  - Denver, Colorado, Forente stater, 80220
    - University of Colorado Cancer Center
- Connecticut
  - Norwalk, Connecticut, Forente stater, 06856
    - Whittingham Cancer Center
- District of Columbia
  - Washington, District of Columbia, Forente stater, 20037
    - George Washington University Medical Center
- Florida
  - Boca Raton, Florida, Forente stater, 33428
    - Comprehensive Cancer Care Specialists of Boca Raton
  - Boca Raton, Florida, Forente stater, 33486
    - Center for Hematology-Oncology
  - Fort Lauderdale, Florida, Forente stater, 33308
    - Southeast Florida Hematology-Oncology Group
  - Fort Myers, Florida, Forente stater, 33901
    - Florida Cancer Specialists
  - Gainesville, Florida, Forente stater, 32610-100277
    - Shands Hospital and Clinics, University of Florida
  - Jacksonville, Florida, Forente stater, 32209
    - University of Florida Health Science Center - Jacksonville
  - Jacksonville, Florida, Forente stater, 32207
    - Hematology and Oncology Associates of Jacksonville
  - Lakeland, Florida, Forente stater, 33804
    - Lakeland Regional Medical Center
  - Leesburg, Florida, Forente stater, 34748
    - Lake Heart and Cancer Medical Center
  - Miami, Florida, Forente stater, 33176
    - Oncology-Hematology Group of South Florida
  - Orlando, Florida, Forente stater, 32804
    - Hematology and Oncology Consultants, P.A.
  - Port Saint Lucie, Florida, Forente stater, 34952
    - Hematology/Oncology Associates
  - Tamarac, Florida, Forente stater, 33321
    - Oncology & Hematology Associates of West Broward
  - Tampa, Florida, Forente stater, 33613
    - University Community Hospital
  - Titusville, Florida, Forente stater, 32796
    - Hematology and Oncology Consultants
- Idaho
  - Coeur d'Alene, Idaho, Forente stater, 83814
    - North Idaho Cancer Center
- Illinois
  - Arlington Heights, Illinois, Forente stater, 60004
    - Northwest Medical Specialists, P.C.
  - Aurora, Illinois, Forente stater, 60506
    - Dreyer Medical Clinic
  - Chicago, Illinois, Forente stater, 60611
    - Northwestern Medical Faculty Foundation
- Indiana
  - New Albany, Indiana, Forente stater, 47150
    - Cancer Care Center
- Kentucky
  - Lexington, Kentucky, Forente stater, 40536-0084
    - Albert B. Chandler Medical Center, University of Kentucky
  - Louisville, Kentucky, Forente stater, 40202
    - James Graham Brown Cancer Center
  - Louisville, Kentucky, Forente stater, 40202
    - Kentuckiana Cancer Institute
  - Louisville, Kentucky, Forente stater, 40202
    - Norton Healthcare Pavilion
  - Louisville, Kentucky, Forente stater, 40206
    - Veterans Affairs Medical Center - Louisville
- Louisiana
  - Baton Rouge, Louisiana, Forente stater, 70806
    - Baton Rouge General Medical Center
  - Lafayette, Louisiana, Forente stater, 70506
    - Louisiana Oncology Associates
  - Metairie, Louisiana, Forente stater, 70006
    - Doctors Hospital of Jefferson
  - New Orleans, Louisiana, Forente stater, 70112
    - Stanley Scott Cancer Center
- Maryland
  - Baltimore, Maryland, Forente stater, 21204
    - Greater Baltimore Medical Center and Cancer Center
- Massachusetts
  - Boston, Massachusetts, Forente stater, 02120
    - Medical Center of Boston
  - Pittsfield, Massachusetts, Forente stater, 01201
    - Berkshire Hematology Oncology, P.C.
- Michigan
  - Detroit, Michigan, Forente stater, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Flint, Michigan, Forente stater, 48532
- Minnesota
  - Roseville, Minnesota, Forente stater, 55113
    - Parker Hughes Cancer Center
- Mississippi
  - Jackson, Mississippi, Forente stater, 39202
    - Jackson Oncology Associates, PLLC
- Missouri
  - Kansas City, Missouri, Forente stater, 64128
    - Veterans Affairs Medical Center - Kansas City
  - Saint Louis, Missouri, Forente stater, 63110
    - Siteman Cancer Center
  - Saint Louis, Missouri, Forente stater, 63141
    - St. John's Mercy Medical Center
  - St. Charles, Missouri, Forente stater, 63301
    - Missouri Cancer Care, P.C.
- Montana
  - Great Falls, Montana, Forente stater, 59405
    - Great Falls Clinic
  - Missoula, Montana, Forente stater, 59807-7609
    - Western Montana Clinic
- New Jersey
  - Somerville, New Jersey, Forente stater, 08876
    - Somerset Medical Center
  - Voorhees, New Jersey, Forente stater, 08043
    - Cooper Cancer Institute
- New York
  - Albany, New York, Forente stater, 12208
    - Veterans Affairs Medical Center - Albany
  - Bronx, New York, Forente stater, 10467-2490
    - Montefiore Medical Center
  - Fresh Meadows, New York, Forente stater, 11365
    - Queens Medical Associates, PC
  - Jamaica, New York, Forente stater, 11432
    - Queens Hospital Center
  - Rochester, New York, Forente stater, 14623
    - Interlakes Oncology/Hematology PC
  - Valhalla, New York, Forente stater, 10595
    - New York Medical College
- North Carolina
  - Chapel Hill, North Carolina, Forente stater, 27599-7295
    - Lineberger Comprehensive Cancer Center, UNC
  - Raleigh, North Carolina, Forente stater, 27609
    - Raleigh Hematology/Oncology Associates - Wake Practice
  - Winston-Salem, North Carolina, Forente stater, 27103
    - Piedmont Hematology-Oncology Associates
- Ohio
  - Cleveland, Ohio, Forente stater, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Columbus, Ohio, Forente stater, 43235
    - Hematology Oncology Consultants Inc
- Oregon
  - Bend, Oregon, Forente stater, 97701
    - Bend Memorial Clinic
  - Portland, Oregon, Forente stater, 97227
    - Kaiser Permanente - Portland
- Pennsylvania
  - Harrisburg, Pennsylvania, Forente stater, 17105-8700
    - Pinnacle Health Hospitals
  - Meadowbrook, Pennsylvania, Forente stater, 18974
    - Abington Hematology Oncology Associates, Incorporated
  - Philadelphia, Pennsylvania, Forente stater, 19104
    - University of Pennsylvania Cancer Center
  - Philadelphia, Pennsylvania, Forente stater, 19106
    - Pennsylvania Oncology Hematology Associates
  - Pittsburgh, Pennsylvania, Forente stater, 15213
    - University of Pittsburgh Cancer Institute
- Rhode Island
  - Providence, Rhode Island, Forente stater, 02906
    - Lifespan: The Miriam Hospital
- South Carolina
  - Greenville, South Carolina, Forente stater, 29615
    - Cancer Centers of the Carolinas
  - Greenville, South Carolina, Forente stater, 27834
    - Physicians East - Quadrangle
- Tennessee
  - Chattanooga, Tennessee, Forente stater, 37403
    - Erlanger Health Systems
  - Knoxville, Tennessee, Forente stater, 37901
    - Baptist Regional Cancer Center - Knoxville
  - Memphis, Tennessee, Forente stater, 38119
    - Memphis Cancer Center
  - Memphis, Tennessee, Forente stater, 38117
    - West Clinic
  - Nashville, Tennessee, Forente stater, 37232-6307
    - Vanderbilt-Ingram Cancer Center
  - Nashville, Tennessee, Forente stater, 37205
    - Tennessee Oncology, P.L.L.C.
- Texas
  - Austin, Texas, Forente stater, 78759
    - Lone Star Oncology
  - Dallas, Texas, Forente stater, 75230
    - Center for Oncology Research and Treatment, Medical City Hospital
  - San Antonio, Texas, Forente stater, 78205
    - Baptist Health System Cancer Program
- Utah
  - Salt Lake City, Utah, Forente stater, 84112
    - Huntsman Cancer Institute
- Virginia
  - Charlottesville, Virginia, Forente stater, 22908
    - Cancer Center at the University of Virginia
  - Fredericksburg, Virginia, Forente stater, 22401
    - Hematology-Oncology Associates of Frederiksburg, Inc.
- Washington
  - Seattle, Washington, Forente stater, 98101
    - Virginia Mason Medical Center
- Wisconsin
  - Milwaukee, Wisconsin, Forente stater, 53209
    - Advanced Health Care
  - Wausau, Wisconsin, Forente stater, 54401
    - UW Cancer Center Wausau Hospital
- Wyoming
  - Laramie, Wyoming, Forente 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
Storbritannia
- England
  - Guildford, England, Storbritannia, GU2 5XX
    - St. Luke's Cancer Center
  - London, England, Storbritannia, SE1 9RT
    - Guy's and St. Thomas' Hospitals NHS Trust
  - London, England, Storbritannia, W6 8RF
    - Charing Cross Hospital
  - London, England, Storbritannia, EC1A 7BE
    - St. Bartholomew's Hospital
  - Maidstone, England, Storbritannia, ME16 9QQ
    - Maidstone Hospital
  - Manchester, England, Storbritannia, M20 4BX
    - Christie Hospital N.H.S. Trust
  - Plymouth, England, Storbritannia, PL6 8DH
    - Derriford Hospital
  - Sheffield, England, Storbritannia, S1O 2SJ
    - Weston Park Hospital
  - Sutton, England, Storbritannia, SM2 5PT
    - Royal Marsden Hospital
- Scotland
  - Aberdeen, Scotland, Storbritannia, AB25 2ZN
    - Aberdeen Royal Infirmary
Tsjekkisk Republikk
- - Ceske Budejovice, Tsjekkisk Republikk, 370 01
    - Centre of Clinical Oncology and Radiation Oncology
  - Hradec Kralove, Tsjekkisk Republikk, 500 02
    - Charles University Hospital
  - Prague, Tsjekkisk Republikk, 128 08
    - Onkologicka Klinka A Onkologicka Lab
  - Praha, Tsjekkisk Republikk, 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Masking: Ingen (Open Label)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sanofi

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2000

Studiet fullført (Faktiske)

1. oktober 2008

Datoer for studieregistrering

Først innsendt

3. mars 2001

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

19. desember 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. desember 2013

Sist bekreftet

1. oktober 2002

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CDR0000068524
SANOFI-EFC4585

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .