Clinical trial NCT00040183: OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.
Official title: A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: Tarceva, EGFR, erlotinib, OSI-774
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Canadian Cancer Trials Group
First posted: 2002-06-25
Enrollment: 569
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if OSI-774 will improve overall survival when combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas;cancer which is unresectable, locally advanced or metastatic.

Must have evidence of disease (clinical or radiological). Male or female, 18 years or older. Patients may have received prior radiation treatment for management of local disease providing that disease progression has been documented.

All toxicities have resolved, and the last fraction of radiation treatment was completed at least 4 weeks prior to randomization.

Patients may not have received prior chemotherapy, other then 5FU (+/- folic acid) or gemcitabine given concurrently with radiation treatment as a 'radiosensitiser.'

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Institute
state: California
city: Los Angeles
country: United States
facility: Metropolitan Hematology/Oncology Medical Group, Inc.
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Manchester
country: United States
facility: DeQuattro Community Cancer Center
state: Connecticut
city: New Britain
country: United States
facility: New Britain General Hospital
state: Connecticut
city: Norwich
country: United States
facility: Eastern Connecticut Oncology
state: Connecticut
city: Stamford
country: United States
facility: Carl and Dorothy Bennett Cancer Center
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Miami
country: United States
facility: Oncology Hematology Group of South Florida
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Atlanta Cancer Center
state: Georgia
city: Peoria
country: United States
facility: Onc/Hem Associates of Central Illinois
state: Illinois
city: Skokie
country: United States
facility: Hematology Oncology Associates of Illinois
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospital & Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare, Inc.
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Metairie
country: United States
facility: J Gurtler, Hematology and Oncology
state: Louisiana
city: Annapolis
country: United States
facility: Annapolis Medical Specialists
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital
state: Maryland
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: St Elizabeth Medical Center
state: Massachusetts
city: Boston
country: United States
facility: New England Medical Center
state: Massachusetts
city: Pittsfield
country: United States
facility: Berkshire Hematology & Oncology, PC
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Oncology and Hematology Group
state: Missouri
city: Hooksett
country: United States
facility: New Hampshire Oncology-Hematology PA
state: New Hampshire
city: Livingston
country: United States
facility: St Barnabas Medical Center
state: New Jersey
city: Great Neck
country: United States
facility: Arena Oncology Associates
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: St Luke's-Roosevelt Hospital
state: New York
city: Rochester
country: United States
facility: Interlakes Oncology & Hematology, P.C.
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Bismarck
country: United States
facility: Odyssey Research Services
state: North Dakota
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Portland
country: United States
facility: Chiles Research Cancer Center
state: Oregon
city: Dunmore
country: United States
facility: Hematology & Oncolgy Assoc of NE PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Oncology Hematology Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology/Oncology
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Cancer Centre
state: Texas
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Tyler
country: United States
facility: Tyler Hematology Oncology PA
state: Texas
city: Bennington
country: United States
facility: Green Mountain Oncology Group
state: Vermont
city: Richmond
country: United States
facility: Hematology & Oncology Associates of Virginia, Ltd.
state: Virginia
city: Olympia
country: United States
facility: Western Washington Oncology Inc.
state: Washington
city: Vancouver
country: United States
facility: Southwest Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Oncology of Wisconsin
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Britanico
city: Buenos Aires
country: Argentina
facility: Instituto Oncologico Angel Roffo
city: Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
city: Buenos Aires
country: Argentina
facility: Hospital Churruca Visca
city: Buenos Aires
country: Argentina
facility: Centro Medico Confidence
city: Concord
country: Australia
facility: Concord Hospital
state: New South Wales
city: HRMC Waratah
country: Australia
facility: Newcastle Mater Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Ashford
country: Australia
facility: Ashford Cancer Centre
state: South Australia
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin & Repatriation Medical Centre
state: Victoria
city: Brussels
country: Belgium
facility: Institute Jules Bordet
city: Salvador
country: Brazil
facility: Nucleo de Oncolgia da Bahia
state: BA
city: Barro Preto
country: Brazil
facility: Hospital Vera Cruz S/A
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
state: RS
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SP
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer Centre for the Southern Interior
state: British Columbia
city: Pentincton
country: Canada
facility: Pentincton Regional Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Fraser Valley Cancer Centre
state: British Columbia
city: Vancouver
country: Canada
facility: BCCA VAncouver Centre
state: British Columbia
city: Victoria
country: Canada
facility: BCCA- Vancouver Island Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba (CCMB)
state: Manitoba
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: St. John's
country: Canada
facility: Dr. H. Bliss Murphy Cancer Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Regional Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Regional Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Center
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre
state: Ontario
city: Saulte Ste. Marie
country: Canada
facility: Group Health Centre
state: Ontario
city: St. Catharines
country: Canada
facility: Hotel Dieu Health Sciences HospitalNiagra
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto-Sunnybrook Regional Cancer Center
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Toronto
country: Canada
facility: St Joseph's Health Centre
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Hopital Du Sacre-Coeur
state: Quebec
city: Ste-Foy
country: Canada
facility: Hopital Laval
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Las Condes
country: Chile
facility: Clinica Las Condes
city: Berlin
country: Germany
facility: Charite Campus Virchow Klinikum
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Freiburg
country: Germany
facility: Tumor Biology Center
city: Hamburg
country: Germany
facility: Universitatskliniken des Saarlands Innere Medizin II
city: Heidelberg
country: Germany
facility: Innere MedizinUniversitatsklinikum Heidelberg
city: Homburg
country: Germany
facility: Universitatskliniken des Saarlands
city: Wurzburg
country: Germany
facility: Medizinische Poliklinik der Universitaet Wurzburg
city: Thessaloniki
country: Greece
facility: Anticancer Hospital of Thessaloniki "THEAGENIO"
city: Thessaloniki
country: Greece
facility: District General Hospital of Thessaloniki "HIPPOKRATION"
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petach Tiqva
country: Israel
facility: Rabin Medical Center (Belinson Campus)
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center (Ichikov)
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico A.O.V.P. Oncologia Medica
city: Mexico City
country: Mexico
facility: Instituto Nacional De Cancerologia
city: Auckland
country: New Zealand
facility: Auckland Hospital
city: Christchurch
country: New Zealand
facility: Christchurch HospitalClinical Oncology Hospital
city: Poznan
country: Poland
facility: Great Poland Cancer Centre
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii
city: Cluj-Napoca
country: Romania
facility: Oncology Institute Ion Chiricuta
city: Iasi
country: Romania
facility: St. Spiridon University Hospital
city: Sibiu
country: Romania
facility: Clinical County Hospital Sibiu
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Oxford
country: United Kingdom
facility: ICRF Medical Oncology Unit
state: Oxfordshire
city: Cardiff
country: United Kingdom
facility: Velindre Hospital
state: Wales
city: Dudley
country: United Kingdom
facility: Russell's Hall HospitalDepartment of OncologyGeorgina Unit
state: West Midlands
city: Wolverhampton
country: United Kingdom
facility: Deanesly Centre
state: West Midlands
city: Hull
country: United Kingdom
facility: The Princess Royal Hospital
city: London
country: United Kingdom
facility: St. Bartholomews Hospital
city: London
country: United Kingdom
facility: North Middlesex Hospital
city: Manchester
country: United Kingdom
facility: Department of Medical Oncology
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Newcastle General Hospital
Study officials:
References:
citation: Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W; National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 May 20;25(15):1960-6. doi: 10.1200/JCO.2006.07.9525. Epub 2007 Apr 23.
citation: Shultz DB, Pai J, Chiu W, Ng K, Hellendag MG, Heestand G, Chang DT, Tu D, Moore MJ, Parulekar WR, Koong AC. A Novel Biomarker Panel Examining Response to Gemcitabine with or without Erlotinib for Pancreatic Cancer Therapy in NCIC Clinical Trials Group PA.3. PLoS One. 2016 Jan 25;11(1):e0147995. doi: 10.1371/journal.pone.0147995. eCollection 2016.