OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.
A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
1 other identifier
interventional
569
17 countries
140
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pancreatic-cancer
Started Nov 2001
Shorter than P25 for phase_3 pancreatic-cancer
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 29, 2001
CompletedFirst Submitted
Initial submission to the registry
June 21, 2002
CompletedFirst Posted
Study publicly available on registry
June 25, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2004
CompletedJanuary 10, 2018
June 1, 2015
2.1 years
June 21, 2002
January 8, 2018
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.'
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OSI Pharmaceuticalslead
- Canadian Cancer Trials Groupcollaborator
Study Sites (140)
Arizona Clinical Research Center
Tucson, Arizona, 85715, United States
Highlands Oncology Group
Springdale, Arkansas, 72764, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704, United States
Loma Linda University Cancer Institute
Loma Linda, California, 92354, United States
Metropolitan Hematology/Oncology Medical Group, Inc.
Los Angeles, California, 90057, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Kaiser Permanente
San Diego, California, 92120, United States
DeQuattro Community Cancer Center
Manchester, Connecticut, 06040, United States
New Britain General Hospital
New Britain, Connecticut, 06050, United States
Eastern Connecticut Oncology
Norwich, Connecticut, 06360-2910, United States
Carl and Dorothy Bennett Cancer Center
Stamford, Connecticut, 06902-3628, United States
Florida Cancer Specialists
Fort Myers, Florida, 34135-4251, United States
Oncology Hematology Group of South Florida
Miami, Florida, 33176, United States
Ocala Oncology
Ocala, Florida, 34474, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Atlanta Cancer Center
Atlanta, Georgia, 30342, United States
Onc/Hem Associates of Central Illinois
Peoria, Illinois, 61602, United States
Hematology Oncology Associates of Illinois
Skokie, Illinois, 60077, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
University of Iowa Hospital & Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky
Lexington, Kentucky, 40536-0098, United States
Norton Healthcare, Inc.
Louisville, Kentucky, 40202, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
J Gurtler, Hematology and Oncology
Metairie, Louisiana, 70006, United States
Annapolis Medical Specialists
Annapolis, Maryland, 21401, United States
Sinai Hospital
Baltimore, Maryland, 21215, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
St Elizabeth Medical Center
Boston, Massachusetts, 01235, United States
New England Medical Center
Boston, Massachusetts, 02111, United States
Berkshire Hematology & Oncology, PC
Pittsfield, Massachusetts, 012018298, United States
Baystate Medical Center
Springfield, Massachusetts, 01107, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Kansas City Oncology and Hematology Group
Kansas City, Missouri, 64111, United States
New Hampshire Oncology-Hematology PA
Hooksett, New Hampshire, 03106, United States
St Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Arena Oncology Associates
Great Neck, New York, 11021, United States
New York University School of Medicine
New York, New York, 10016, United States
St Luke's-Roosevelt Hospital
New York, New York, 10019, United States
Interlakes Oncology & Hematology, P.C.
Rochester, New York, 14623, United States
Stony Brook University Hospital
Stony Brook, New York, 11794-8174, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
Odyssey Research Services
Bismarck, North Dakota, 58501, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106-7832, United States
Chiles Research Cancer Center
Portland, Oregon, 97213-2967, United States
Hematology & Oncolgy Assoc of NE PA
Dunmore, Pennsylvania, 18512, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19106, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Charleston Hematology/Oncology
Charleston, South Carolina, 29403, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Arlington Cancer Centre
Arlington, Texas, 76012, United States
Southwest Regional Cancer Center
Austin, Texas, 78705, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Tyler Hematology Oncology PA
Tyler, Texas, 75701, United States
Green Mountain Oncology Group
Bennington, Vermont, 05201, United States
Hematology & Oncology Associates of Virginia, Ltd.
Richmond, Virginia, 23226, United States
Western Washington Oncology Inc.
Olympia, Washington, 98502, United States
Southwest Washington Medical Center
Vancouver, Washington, 98664, United States
Oncology of Wisconsin
Milwaukee, Wisconsin, 53215, United States
Hospital Italiano de Buenos Aires
Buenos Aires, CP 1181, Argentina
Hospital Britanico
Buenos Aires, CP 1280, Argentina
Instituto Oncologico Angel Roffo
Buenos Aires, CP 1417, Argentina
Instituto Alexander Fleming
Buenos Aires, CP 1426, Argentina
Hospital Churruca Visca
Buenos Aires, CP 1437, Argentina
Centro Medico Confidence
Buenos Aires, CP 1642, Argentina
Concord Hospital
Concord, New South Wales, 2139, Australia
Newcastle Mater Hospital
HRMC Waratah, New South Wales, 2310, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Ashford Cancer Centre
Ashford, South Australia, 5035, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Frankston Hospital
Frankston, Victoria, 3199, Australia
Austin & Repatriation Medical Centre
Heidelberg, Victoria, 3084, Australia
Institute Jules Bordet
Brussels, Belgium
Nucleo de Oncolgia da Bahia
Salvador, Estado de Bahia, 40170-070, Brazil
Hospital Vera Cruz S/A
Barro Prêto, Minas Gerais, CEP 30190-130, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, CEP 90020-090, Brazil
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05651-901, Brazil
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
Pentincton Regional Hospital
Pentincton, British Columbia, V2A 3G6, Canada
Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2, Canada
BCCA VAncouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
BCCA- Vancouver Island Centre
Victoria, British Columbia, V8R 6V5, Canada
CancerCare Manitoba (CCMB)
Winnipeg, Manitoba, R2H 2A6, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9, Canada
London Regional Cancer Center
London, Ontario, N6A 4L6, Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2V8, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4, Canada
Group Health Centre
Saulte Ste. Marie, Ontario, P6B 1Y5, Canada
Hotel Dieu Health Sciences HospitalNiagra
St. Catharines, Ontario, L2R 5K3, Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7, Canada
Toronto-Sunnybrook Regional Cancer Center
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
St Joseph's Health Centre
Toronto, Ontario, M6R 1B5, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Hopital Du Sacre-Coeur
Montreal, Quebec, H4J 2C5, Canada
Hopital Laval
Ste-Foy, Quebec, G1V 4G5, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Clinica Las Condes
Las Condes, Chile
Charite Campus Virchow Klinikum
Berlin, 13353, Germany
Universitatsklinikum Essen
Essen, 45122, Germany
Tumor Biology Center
Freiburg im Breisgau, D-79106, Germany
Universitatskliniken des Saarlands Innere Medizin II
Hamburg, 66421, Germany
Innere MedizinUniversitatsklinikum Heidelberg
Heidelberg, Germany
Universitatskliniken des Saarlands
Homburg, 66421, Germany
Medizinische Poliklinik der Universitaet Wurzburg
Würzburg, 97070, Germany
Anticancer Hospital of Thessaloniki "THEAGENIO"
Thessaloniki, 546 39, Greece
District General Hospital of Thessaloniki "HIPPOKRATION"
Thessaloniki, 546 39, Greece
Rambam Medical Center
Haifa, 31096, Israel
Rabin Medical Center (Belinson Campus)
Petach Tiqva, 49100, Israel
Kaplan Medical Center
Rehovot, Israel
Sourasky Medical Center (Ichikov)
Tel Aviv, 64239, Israel
Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Azienda Ospedaliera Universitaria Policlinico A.O.V.P. Oncologia Medica
Palermo, 90127, Italy
Instituto Nacional De Cancerologia
Mexico City, 14000, Mexico
Auckland Hospital
Auckland, 92019, New Zealand
Christchurch HospitalClinical Oncology Hospital
Christchurch, New Zealand
Great Poland Cancer Centre
Poznan, 61 866, Poland
Dolnoslaskie Centrum Onkologii
Wroclaw, 53-413, Poland
Oncology Institute Ion Chiricuta
Cluj-Napoca, 3400, Romania
St. Spiridon University Hospital
Iași, 6600, Romania
Clinical County Hospital Sibiu
Sibiu, 2400, Romania
National University Hospital
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
National Cancer Centre
Singapore, 169610, Singapore
ICRF Medical Oncology Unit
Oxford, Oxfordshire, OX3 7LJ, United Kingdom
Velindre Hospital
Cardiff, Wales, CF14 2TL, United Kingdom
Russell's Hall HospitalDepartment of OncologyGeorgina Unit
Dudley, West Midlands, DY8 5QX, United Kingdom
Deanesly Centre
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
The Princess Royal Hospital
Hull, HU8 9HE, United Kingdom
St. Bartholomews Hospital
London, EC1A 7BE, United Kingdom
North Middlesex Hospital
London, N18 1QX, United Kingdom
Department of Medical Oncology
Manchester, M20 4BX, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, NE4 6BE, United Kingdom
Related Publications (2)
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.
PMID: 17452677BACKGROUNDShultz 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.
PMID: 26808546DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2002
First Posted
June 25, 2002
Study Start
November 29, 2001
Primary Completion
January 15, 2004
Study Completion
January 15, 2004
Last Updated
January 10, 2018
Record last verified: 2015-06