Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

18 dicembre 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Cancro colorettale

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Fase

Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Mascheramento: Nessuno (etichetta aperta)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sanofi

Investigatori

Cattedra di studio: Daniel G. Haller, MD, Abramson Cancer Center of the University of Pennsylvania

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2000

Completamento dello studio (Effettivo)

1 ottobre 2008

Date di iscrizione allo studio

Primo inviato

3 marzo 2001

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2003

Primo Inserito (Stima)

27 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 dicembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 dicembre 2013

Ultimo verificato

1 ottobre 2002

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

CDR0000068524
SANOFI-EFC4585

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .