OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00040183
- Lead Sponsor
- OSI Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 569
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.'
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (140)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Atlanta Cancer Center
🇺🇸Atlanta, Georgia, United States
St Elizabeth Medical Center
🇺🇸Boston, Massachusetts, United States
New England Medical Center
🇺🇸Boston, Massachusetts, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Instituto Nacional De Cancerologia
🇲🇽Mexico City, Mexico
Kaiser Permanente
🇺🇸San Diego, California, United States
Oncology Hematology Group of South Florida
🇺🇸Miami, Florida, United States
Hospital Vera Cruz S/A
🇧🇷Barro Preto, Minas Gerais, Brazil
Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
St Luke's-Roosevelt Hospital
🇺🇸New York, New York, United States
Arlington Cancer Centre
🇺🇸Arlington, Texas, United States
Interlakes Oncology & Hematology, P.C.
🇺🇸Rochester, New York, United States
Hematology & Oncology Associates of Virginia, Ltd.
🇺🇸Richmond, Virginia, United States
New Hampshire Oncology-Hematology PA
🇺🇸Hooksett, New Hampshire, United States
Instituto Alexander Fleming
🇦🇷Buenos Aires, Argentina
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Eastern Connecticut Oncology
🇺🇸Norwich, Connecticut, United States
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Norton Healthcare, Inc.
🇺🇸Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Ocala Oncology
🇺🇸Ocala, Florida, United States
Berkshire Hematology & Oncology, PC
🇺🇸Pittsfield, Massachusetts, United States
Kansas City Oncology and Hematology Group
🇺🇸Kansas City, Missouri, United States
St Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Arena Oncology Associates
🇺🇸Great Neck, New York, United States
Odyssey Research Services
🇺🇸Bismarck, North Dakota, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Chiles Research Cancer Center
🇺🇸Portland, Oregon, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Group Health Centre
🇨🇦Saulte Ste. Marie, Ontario, Canada
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Hospital Israelita Albert Einstein
🇧🇷Sao Paulo, SP, Brazil
BCCA- Vancouver Island Centre
🇨🇦Victoria, British Columbia, Canada
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
St Joseph's Health Centre
🇨🇦Toronto, Ontario, Canada
Charite Campus Virchow Klinikum
🇩🇪Berlin, Germany
Kaplan Medical Center
🇮🇱Rehovot, Israel
Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Sourasky Medical Center (Ichikov)
🇮🇱Tel Aviv, Israel
BC Cancer Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
Pentincton Regional Hospital
🇨🇦Pentincton, British Columbia, Canada
BCCA VAncouver Centre
🇨🇦Vancouver, British Columbia, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Hopital Du Sacre-Coeur
🇨🇦Montreal, Quebec, Canada
Christchurch HospitalClinical Oncology Hospital
🇳🇿Christchurch, New Zealand
Newcastle General Hospital
🇬🇧Newcastle-Upon-Tyne, United Kingdom
Rabin Medical Center (Belinson Campus)
🇮🇱Petach Tiqva, Israel
Medizinische Poliklinik der Universitaet Wurzburg
🇩🇪Wurzburg, Germany
Clinica Las Condes
🇨🇱Las Condes, Chile
St. Bartholomews Hospital
🇬🇧London, United Kingdom
Universitatskliniken des Saarlands Innere Medizin II
🇩🇪Hamburg, Germany
Universitatsklinikum Essen
🇩🇪Essen, Germany
Rambam Medical Center
🇮🇱Haifa, Israel
Clinical County Hospital Sibiu
🇷🇴Sibiu, Romania
National Cancer Centre
🇸🇬Singapore, Singapore
Anticancer Hospital of Thessaloniki "THEAGENIO"
🇬🇷Thessaloniki, Greece
Dolnoslaskie Centrum Onkologii
🇵🇱Wroclaw, Poland
National University Hospital
🇸🇬Singapore, Singapore
Auckland Hospital
🇳🇿Auckland, New Zealand
District General Hospital of Thessaloniki "HIPPOKRATION"
🇬🇷Thessaloniki, Greece
Azienda Ospedaliera Universitaria Policlinico A.O.V.P. Oncologia Medica
🇮🇹Palermo, Italy
Oncology Institute Ion Chiricuta
🇷🇴Cluj-Napoca, Romania
Tumor Biology Center
🇩🇪Freiburg, Germany
St. Spiridon University Hospital
🇷🇴Iasi, Romania
London Regional Cancer Center
🇨🇦London, Ontario, Canada
DeQuattro Community Cancer Center
🇺🇸Manchester, Connecticut, United States
Carl and Dorothy Bennett Cancer Center
🇺🇸Stamford, Connecticut, United States
New Britain General Hospital
🇺🇸New Britain, Connecticut, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Onc/Hem Associates of Central Illinois
🇺🇸Peoria, Illinois, United States
Hematology Oncology Associates of Illinois
🇺🇸Skokie, Illinois, United States
University of Iowa Hospital & Clinics
🇺🇸Iowa City, Iowa, United States
Sinai Hospital
🇺🇸Baltimore, Maryland, United States
Annapolis Medical Specialists
🇺🇸Annapolis, Maryland, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Hematology & Oncolgy Assoc of NE PA
🇺🇸Dunmore, Pennsylvania, United States
Pennsylvania Oncology Hematology Associates
🇺🇸Philadelphia, Pennsylvania, United States
Charleston Hematology/Oncology
🇺🇸Charleston, South Carolina, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
Tyler Hematology Oncology PA
🇺🇸Tyler, Texas, United States
Oncology of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Southwest Washington Medical Center
🇺🇸Vancouver, Washington, United States
Western Washington Oncology Inc.
🇺🇸Olympia, Washington, United States
Hospital Britanico
🇦🇷Buenos Aires, Argentina
Instituto Oncologico Angel Roffo
🇦🇷Buenos Aires, Argentina
Concord Hospital
🇦🇺Concord, New South Wales, Australia
Centro Medico Confidence
🇦🇷Buenos Aires, Argentina
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Hospital Churruca Visca
🇦🇷Buenos Aires, Argentina
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Newcastle Mater Hospital
🇦🇺HRMC Waratah, New South Wales, Australia
Ashford Cancer Centre
🇦🇺Ashford, South Australia, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
Institute Jules Bordet
🇧🇪Brussels, Belgium
Irmandade Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Nucleo de Oncolgia da Bahia
🇧🇷Salvador, BA, Brazil
Toronto-Sunnybrook Regional Cancer Center
🇨🇦Toronto, Ontario, Canada
Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
Universitatskliniken des Saarlands
🇩🇪Homburg, Germany
Innere MedizinUniversitatsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Great Poland Cancer Centre
🇵🇱Poznan, Poland
ICRF Medical Oncology Unit
🇬🇧Oxford, Oxfordshire, United Kingdom
Russell's Hall HospitalDepartment of OncologyGeorgina Unit
🇬🇧Dudley, West Midlands, United Kingdom
Deanesly Centre
🇬🇧Wolverhampton, West Midlands, United Kingdom
North Middlesex Hospital
🇬🇧London, United Kingdom
Department of Medical Oncology
🇬🇧Manchester, United Kingdom
The Princess Royal Hospital
🇬🇧Hull, United Kingdom
CancerCare Manitoba (CCMB)
🇨🇦Winnipeg, Manitoba, Canada
Loma Linda University Cancer Institute
🇺🇸Loma Linda, California, United States
Metropolitan Hematology/Oncology Medical Group, Inc.
🇺🇸Los Angeles, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Hotel Dieu Health Sciences HospitalNiagra
🇨🇦St. Catharines, Ontario, Canada
J Gurtler, Hematology and Oncology
🇺🇸Metairie, Louisiana, United States
Green Mountain Oncology Group
🇺🇸Bennington, Vermont, United States
Austin & Repatriation Medical Centre
🇦🇺Heidelberg, Victoria, Australia
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Singapore General Hospital
🇸🇬Singapore, Singapore
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States