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

January 8, 2018 updated by: OSI Pharmaceuticals

A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

569

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, CP 1181
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, CP 1280
        • Hospital Britanico
      • Buenos Aires, Argentina, CP 1417
        • Instituto Oncologico Angel Roffo
      • Buenos Aires, Argentina, CP 1426
        • Instituto Alexander Fleming
      • Buenos Aires, Argentina, CP 1437
        • Hospital Churruca Visca
      • Buenos Aires, Argentina, CP 1642
        • Centro Medico Confidence
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Hospital
      • HRMC Waratah, New South Wales, Australia, 2310
        • Newcastle Mater Hospital
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Ashford, South Australia, Australia, 5035
        • Ashford Cancer Centre
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin & Repatriation Medical Centre
  • Belgium
      • Brussels, Belgium
        • Institute Jules Bordet
  • Brazil
    • BA
      • Salvador, BA, Brazil, 40170-070
        • Nucleo de Oncolgia da Bahia
    • Minas Gerais
      • Barro Preto, Minas Gerais, Brazil, CEP 30190-130
        • Hospital Vera Cruz S/A
    • RS
      • Porto Alegre, RS, Brazil, CEP 90020-090
        • Irmandade Santa Casa de Misericordia de Porto Alegre
    • SP
      • Sao Paulo, SP, Brazil, 05651-901
        • Hospital Israelita Albert Einstein
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BC Cancer Centre for the Southern Interior
      • Pentincton, British Columbia, Canada, V2A 3G6
        • Pentincton Regional Hospital
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Fraser Valley Cancer Centre
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA Vancouver Centre
      • Victoria, British Columbia, Canada, V8R 6V5
        • BCCA- Vancouver Island Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • CancerCare Manitoba (CCMB)
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Dr. H. Bliss Murphy Cancer Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • QEII Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Hamilton Regional Cancer Centre
      • Kingston, Ontario, Canada, K7L 5P9
        • Kingston Regional Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Center
      • Mississauga, Ontario, Canada, L5M 2V8
        • Credit Valley Hospital
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre
      • Saulte Ste. Marie, Ontario, Canada, P6B 1Y5
        • Group Health Centre
      • St. Catharines, Ontario, Canada, L2R 5K3
        • Hotel Dieu Health Sciences HospitalNiagra
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M6R 1B5
        • St Joseph's Health Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto-Sunnybrook Regional Cancer Center
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Hôpital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada, H4J 2C5
        • Hopital Du Sacre-Coeur
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • Hôpital Laval
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • Chile
      • Las Condes, Chile
        • Clinica Las Condes
  • Germany
      • Berlin, Germany, 13353
        • Charite Campus Virchow Klinikum
      • Essen, Germany, 45122
        • Universitätsklinikum Essen
      • Freiburg, Germany, D-79106
        • Tumor Biology Center
      • Hamburg, Germany, 66421
        • Universitatskliniken des Saarlands Innere Medizin II
      • Heidelberg, Germany
        • Innere MedizinUniversitatsklinikum Heidelberg
      • Homburg, Germany, 66421
        • Universitatskliniken des Saarlands
      • Wurzburg, Germany, 97070
        • Medizinische Poliklinik der Universitaet Wurzburg
  • Greece
      • Thessaloniki, Greece, 546 39
        • Anticancer Hospital of Thessaloniki "THEAGENIO"
      • Thessaloniki, Greece, 546 39
        • District General Hospital of Thessaloniki "HIPPOKRATION"
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Petach Tiqva, Israel, 49100
        • Rabin Medical Center (Belinson Campus)
      • Rehovot, Israel
        • Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • Sourasky Medical Center (Ichikov)
      • Tel Hashomer, Israel, 52621
        • Chaim Sheba Medical Center
  • Italy
      • Palermo, Italy, 90127
        • Azienda Ospedaliera Universitaria Policlinico A.O.V.P. Oncologia Medica
  • Mexico
      • Mexico City, Mexico, 14000
        • Instituto Nacional de Cancerologia
  • New Zealand
      • Auckland, New Zealand, 92019
        • Auckland Hospital
      • Christchurch, New Zealand
        • Christchurch HospitalClinical Oncology Hospital
  • Poland
      • Poznan, Poland, 61 866
        • Great Poland Cancer Centre
      • Wroclaw, Poland, 53-413
        • Dolnoslaskie Centrum Onkologii
  • Romania
      • Cluj-Napoca, Romania, 3400
        • Oncology Institute Ion Chiricuta
      • Iasi, Romania, 6600
        • St. Spiridon University Hospital
      • Sibiu, Romania, 2400
        • Clinical County Hospital Sibiu
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 169610
        • National Cancer Centre
  • United Kingdom
      • Hull, United Kingdom, HU8 9HE
        • The Princess Royal Hospital
      • London, United Kingdom, N18 1QX
        • North Middlesex Hospital
      • London, United Kingdom, EC1A 7BE
        • St. Bartholomews Hospital
      • Manchester, United Kingdom, M20 4BX
        • Department of Medical Oncology
      • Newcastle-Upon-Tyne, United Kingdom, NE4 6BE
        • Newcastle General Hospital
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
        • ICRF Medical Oncology Unit
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Velindre Hospital
    • West Midlands
      • Dudley, West Midlands, United Kingdom, DY8 5QX
        • Russell's Hall HospitalDepartment of OncologyGeorgina Unit
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • Deanesly Centre
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Arizona Clinical Research Center
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Highlands Oncology Group
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Cancer Institute
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Los Angeles, California, United States, 90057
        • Metropolitan Hematology/Oncology Medical Group, Inc.
      • San Diego, California, United States, 92120
        • Kaiser Permanente
    • Connecticut
      • Manchester, Connecticut, United States, 06040
        • DeQuattro Community Cancer Center
      • New Britain, Connecticut, United States, 06050
        • New Britain General Hospital
      • Norwich, Connecticut, United States, 06360-2910
        • Eastern Connecticut Oncology
      • Stamford, Connecticut, United States, 06902-3628
        • Carl and Dorothy Bennett Cancer Center
    • Florida
      • Fort Myers, Florida, United States, 34135-4251
        • Florida Cancer Specialists
      • Miami, Florida, United States, 33176
        • Oncology Hematology Group of South Florida
      • Ocala, Florida, United States, 34474
        • Ocala Oncology
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Cancer Center
    • Illinois
      • Peoria, Illinois, United States, 61602
        • Onc/Hem Associates of Central Illinois
      • Skokie, Illinois, United States, 60077
        • Hematology Oncology Associates of Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital & Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0098
        • University of Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare, Inc.
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
      • Metairie, Louisiana, United States, 70006
        • J Gurtler, Hematology and Oncology
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Annapolis Medical Specialists
      • Baltimore, Maryland, United States, 21231
        • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Medical Center
      • Boston, Massachusetts, United States, 01235
        • St Elizabeth Medical Center
      • Pittsfield, Massachusetts, United States, 012018298
        • Berkshire Hematology & Oncology, PC
      • Springfield, Massachusetts, United States, 01107
        • Baystate Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Oncology and Hematology Group
    • New Hampshire
      • Hooksett, New Hampshire, United States, 03106
        • New Hampshire Oncology-Hematology PA
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • St Barnabas Medical Center
    • New York
      • Great Neck, New York, United States, 11021
        • Arena Oncology Associates
      • New York, New York, United States, 10016
        • New York University School of Medicine
      • New York, New York, United States, 10019
        • St Luke's-Roosevelt Hospital
      • Rochester, New York, United States, 14623
        • Interlakes Oncology & Hematology, P.C.
      • Stony Brook, New York, United States, 11794-8174
        • Stony Brook University Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Odyssey Research Services
    • Ohio
      • Cleveland, Ohio, United States, 44106-7832
        • University Hospitals of Cleveland
    • Oregon
      • Portland, Oregon, United States, 97213-2967
        • Chiles Research Cancer Center
    • Pennsylvania
      • Dunmore, Pennsylvania, United States, 18512
        • Hematology & Oncolgy Assoc of NE PA
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Cancer Center
      • Philadelphia, Pennsylvania, United States, 19106
        • Pennsylvania Oncology Hematology Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology/Oncology
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Center
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Cancer Centre
      • Austin, Texas, United States, 78705
        • Southwest Regional Cancer Center
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Tyler, Texas, United States, 75701
        • Tyler Hematology Oncology PA
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Green Mountain Oncology Group
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Hematology & Oncology Associates of Virginia, Ltd.
    • Washington
      • Olympia, Washington, United States, 98502
        • Western Washington Oncology Inc.
      • Vancouver, Washington, United States, 98664
        • Southwest Washington Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Oncology of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OSI Pharmaceuticals

Collaborators

Canadian Cancer Trials Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2001

Primary Completion (Actual)

January 15, 2004

Study Completion (Actual)

January 15, 2004

Study Registration Dates

First Submitted

June 21, 2002

First Submitted That Met QC Criteria

June 24, 2002

First Posted (Estimate)

June 25, 2002

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA.3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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