OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.

Last updated: January 8, 2018
Sponsor: OSI Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Pancreatic Cancer

Pancreatic Disorders

Cancer

Treatment

N/A

Clinical Study ID

NCT00040183
PA.3
  • Ages 18-120
  • All Genders

Study 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

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.'

Study Design

Total Participants: 569
Study Start date:
November 29, 2001
Estimated Completion Date:
January 15, 2004

Connect with a study center

  • Centro Medico Confidence

    Buenos Aires, CP 1642
    Argentina

    Site Not Available

  • Hospital Britanico

    Buenos Aires, CP 1280
    Argentina

    Site Not Available

  • Hospital Churruca Visca

    Buenos Aires, CP 1437
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Buenos Aires, CP 1181
    Argentina

    Site Not Available

  • Instituto Alexander Fleming

    Buenos Aires, CP 1426
    Argentina

    Site Not Available

  • Instituto Oncologico Angel Roffo

    Buenos Aires, CP 1417
    Argentina

    Site Not Available

  • Concord Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Newcastle Mater Hospital

    HRMC Waratah, New South Wales 2310
    Australia

    Site Not Available

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Ashford Cancer Centre

    Ashford, South Australia 5035
    Australia

    Site Not Available

  • The Queen Elizabeth Hospital

    Woodville South, South Australia 5011
    Australia

    Site Not Available

  • Frankston Hospital

    Frankston, Victoria 3199
    Australia

    Site Not Available

  • Austin & Repatriation Medical Centre

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Institute Jules Bordet

    1000 Brussels,
    Belgium

    Site Not Available

  • Institute Jules Bordet

    Brussels,
    Belgium

    Site Not Available

  • Nucleo de Oncolgia da Bahia

    Salvador, BA 40170-070
    Brazil

    Site Not Available

  • Hospital Vera Cruz S/A

    Barro Preto, Minas Gerais CEP 30190-130
    Brazil

    Site Not Available

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, RS CEP 90020-090
    Brazil

    Site Not Available

  • Hospital Israelita Albert Einstein

    Sao Paulo, SP 05651-901
    Brazil

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • BC Cancer Centre for the Southern Interior

    Kelowna, British Columbia V1Y 5L3
    Canada

    Site Not Available

  • Pentincton Regional Hospital

    Pentincton, British Columbia V2A 3G6
    Canada

    Site Not Available

  • Fraser Valley Cancer Centre

    Surrey, British Columbia V3V 1Z2
    Canada

    Site Not Available

  • BCCA VAncouver Centre

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • BCCA- Vancouver Island Centre

    Victoria, British Columbia V8R 6V5
    Canada

    Site Not Available

  • CancerCare Manitoba (CCMB)

    Winnipeg, Manitoba R2H 2A6
    Canada

    Site Not Available

  • Saint John Regional Hospital

    Saint John, New Brunswick E2L 4L2
    Canada

    Site Not Available

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador A1B 3V6
    Canada

    Site Not Available

  • QEII Health Sciences Centre

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Hamilton Regional Cancer Centre

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • Kingston Regional Cancer Centre

    Kingston, Ontario K7L 5P9
    Canada

    Site Not Available

  • London Regional Cancer Center

    London, Ontario N6A 4L6
    Canada

    Site Not Available

  • Credit Valley Hospital

    Mississauga, Ontario L5M 2V8
    Canada

    Site Not Available

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario K1H 1C4
    Canada

    Site Not Available

  • Group Health Centre

    Saulte Ste. Marie, Ontario P6B 1Y5
    Canada

    Site Not Available

  • Hotel Dieu Health Sciences HospitalNiagra

    St. Catharines, Ontario L2R 5K3
    Canada

    Site Not Available

  • Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • St Joseph's Health Centre

    Toronto, Ontario M6R 1B5
    Canada

    Site Not Available

  • Toronto East General Hospital

    Toronto, Ontario M4C 3E7
    Canada

    Site Not Available

  • Toronto-Sunnybrook Regional Cancer Center

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Hopital Du Sacre-Coeur

    Montreal, Quebec H4J 2C5
    Canada

    Site Not Available

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Hopital Laval

    Ste-Foy, Quebec G1V 4G5
    Canada

    Site Not Available

  • Allan Blair Cancer Centre

    Regina, Saskatchewan S4T 7T1
    Canada

    Site Not Available

  • Clinica Las Condes

    Las Condes,
    Chile

    Site Not Available

  • Innere MedizinUniversitatsklinikum Heidelberg

    69115 Heidelberg,
    Germany

    Site Not Available

  • Charite Campus Virchow Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • Universitatsklinikum Essen

    Essen, 45122
    Germany

    Site Not Available

  • Tumor Biology Center

    Freiburg, D-79106
    Germany

    Site Not Available

  • Universitatskliniken des Saarlands Innere Medizin II

    Hamburg, 66421
    Germany

    Site Not Available

  • Innere MedizinUniversitatsklinikum Heidelberg

    Heidelberg,
    Germany

    Site Not Available

  • Universitatskliniken des Saarlands

    Homburg, 66421
    Germany

    Site Not Available

  • Medizinische Poliklinik der Universitaet Wurzburg

    Wurzburg, 97070
    Germany

    Site Not Available

  • Anticancer Hospital of Thessaloniki "THEAGENIO"

    Thessaloniki, 546 39
    Greece

    Site Not Available

  • District General Hospital of Thessaloniki "HIPPOKRATION"

    Thessaloniki, 546 39
    Greece

    Site Not Available

  • Rambam Medical Center

    Haifa, 31096
    Israel

    Site Not Available

  • Rabin Medical Center (Belinson Campus)

    Petach Tiqva, 49100
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rehovot,
    Israel

    Site Not Available

  • Sourasky Medical Center (Ichikov)

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Chaim Sheba Medical Center

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico A.O.V.P. Oncologia Medica

    Palermo, 90127
    Italy

    Site Not Available

  • Instituto Nacional De Cancerologia

    Mexico City, 14000
    Mexico

    Site Not Available

  • Auckland Hospital

    Auckland, 92019
    New Zealand

    Site Not Available

  • Christchurch HospitalClinical Oncology Hospital

    Christchurch,
    New Zealand

    Site Not Available

  • Great Poland Cancer Centre

    Poznan, 61 866
    Poland

    Site Not Available

  • Dolnoslaskie Centrum Onkologii

    Wroclaw, 53-413
    Poland

    Site Not Available

  • Oncology Institute Ion Chiricuta

    Cluj-Napoca, 3400
    Romania

    Site Not Available

  • St. Spiridon University Hospital

    Iasi, 6600
    Romania

    Site Not Available

  • Clinical County Hospital Sibiu

    Sibiu, 2400
    Romania

    Site Not Available

  • National Cancer Centre

    Singapore, 169610
    Singapore

    Site Not Available

  • National University Hospital

    Singapore, 119074
    Singapore

    Site Not Available

  • Singapore General Hospital

    Singapore, 169608
    Singapore

    Site Not Available

  • ICRF Medical Oncology Unit

    Oxford, Oxfordshire OX3 7LJ
    United Kingdom

    Site Not Available

  • Velindre Hospital

    Cardiff, Wales CF14 2TL
    United Kingdom

    Site Not Available

  • Russell's Hall HospitalDepartment of OncologyGeorgina Unit

    Dudley, West Midlands DY8 5QX
    United Kingdom

    Site Not Available

  • Deanesly Centre

    Wolverhampton, West Midlands WV10 0QP
    United Kingdom

    Site Not Available

  • The Princess Royal Hospital

    Hull, HU8 9HE
    United Kingdom

    Site Not Available

  • North Middlesex Hospital

    London, N18 1QX
    United Kingdom

    Site Not Available

  • St. Bartholomews Hospital

    London, EC1A 7BE
    United Kingdom

    Site Not Available

  • Department of Medical Oncology

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Newcastle General Hospital

    Newcastle-Upon-Tyne, NE4 6BE
    United Kingdom

    Site Not Available

  • Arizona Clinical Research Center

    Tucson, Arizona 85715
    United States

    Site Not Available

  • Highlands Oncology Group

    Springdale, Arkansas 72764
    United States

    Site Not Available

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California 94704
    United States

    Site Not Available

  • Loma Linda University Cancer Institute

    Loma Linda, California 92354
    United States

    Site Not Available

  • Metropolitan Hematology/Oncology Medical Group, Inc.

    Los Angeles, California 90057
    United States

    Site Not Available

  • UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Kaiser Permanente

    San Diego, California 92120
    United States

    Site Not Available

  • DeQuattro Community Cancer Center

    Manchester, Connecticut 06040
    United States

    Site Not Available

  • New Britain General Hospital

    New Britain, Connecticut 06050
    United States

    Site Not Available

  • Eastern Connecticut Oncology

    Norwich, Connecticut 06360-2910
    United States

    Site Not Available

  • Carl and Dorothy Bennett Cancer Center

    Stamford, Connecticut 06902-3628
    United States

    Site Not Available

  • Florida Cancer Specialists

    Fort Myers, Florida 34135-4251
    United States

    Site Not Available

  • Florida Cancer Specialists

    Ft Myers, Florida 34135-4251
    United States

    Site Not Available

  • Oncology Hematology Group of South Florida

    Miami, Florida 33176
    United States

    Site Not Available

  • Ocala Oncology

    Ocala, Florida 34474
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Atlanta Cancer Center

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Onc/Hem Associates of Central Illinois

    Peoria, Illinois 61602
    United States

    Site Not Available

  • Hematology Oncology Associates of Illinois

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • University of Iowa Hospital & Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536-0098
    United States

    Site Not Available

  • Norton Healthcare, Inc.

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • J Gurtler, Hematology and Oncology

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Annapolis Medical Specialists

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Sinai Hospital

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland 21231
    United States

    Site Not Available

  • New England Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • St Elizabeth Medical Center

    Boston, Massachusetts 01235
    United States

    Site Not Available

  • Berkshire Hematology & Oncology, PC

    Pittsfield, Massachusetts 012018298
    United States

    Site Not Available

  • Baystate Medical Center

    Springfield, Massachusetts 01107
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Kansas City Oncology and Hematology Group

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • New Hampshire Oncology-Hematology PA

    Hooksett, New Hampshire 03106
    United States

    Site Not Available

  • St Barnabas Medical Center

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Arena Oncology Associates

    Great Neck, New York 11021
    United States

    Site Not Available

  • New York University School of Medicine

    New York, New York 10016
    United States

    Site Not Available

  • St Luke's-Roosevelt Hospital

    New York, New York 10019
    United States

    Site Not Available

  • Interlakes Oncology & Hematology, P.C.

    Rochester, New York 14623
    United States

    Site Not Available

  • Stony Brook University Hospital

    Stony Brook, New York 11794-8174
    United States

    Site Not Available

  • Presbyterian Hospital

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Odyssey Research Services

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • University Hospitals of Cleveland

    Cleveland, Ohio 44106-7832
    United States

    Site Not Available

  • Chiles Research Cancer Center

    Portland, Oregon 97213-2967
    United States

    Site Not Available

  • Hematology & Oncolgy Assoc of NE PA

    Dunmore, Pennsylvania 18512
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Pennsylvania Oncology Hematology Associates

    Philadelphia, Pennsylvania 19106
    United States

    Site Not Available

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Charleston Hematology/Oncology

    Charleston, South Carolina 29403
    United States

    Site Not Available

  • Sarah Cannon Cancer Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Arlington Cancer Centre

    Arlington, Texas 76012
    United States

    Site Not Available

  • Southwest Regional Cancer Center

    Austin, Texas 78705
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Tyler Hematology Oncology PA

    Tyler, Texas 75701
    United States

    Site Not Available

  • Green Mountain Oncology Group

    Bennington, Vermont 05201
    United States

    Site Not Available

  • Hematology & Oncology Associates of Virginia, Ltd.

    Richmond, Virginia 23226
    United States

    Site Not Available

  • Western Washington Oncology Inc.

    Olympia, Washington 98502
    United States

    Site Not Available

  • Southwest Washington Medical Center

    Vancouver, Washington 98664
    United States

    Site Not Available

  • Oncology of Wisconsin

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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