CClinicalTrials.gg
CompletedNCT00040183Updated Jan 10, 2018

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

A Phase 3 interventional study of Tarceva (erlotinib HCl, OSI-774) in Pancreatic Cancer, sponsored by OSI Pharmaceuticals. Completed at 140 sites in 17 countries. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-01-10.

Sponsored by OSI Pharmaceuticals · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2001, registered Jun 2002).
Phase
Phase 3
Study type
Interventional
Enrollment
569
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
All
01

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.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • Tarceva, EGFR, erlotinib, OSI-774
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 569 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

OSI Pharmaceuticals is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.'

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
569 participants (actual)

Interventions

  • DrugTarceva (erlotinib HCl, OSI-774)
06

Study locations

140 sites
  • 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, BA 40170-070, Brazil
  • Hospital Vera Cruz S/A
    Barro Preto, Minas Gerais CEP 30190-130, Brazil
  • Irmandade Santa Casa de Misericordia de Porto Alegre
    Porto Alegre, RS CEP 90020-090, Brazil
  • Hospital Israelita Albert Einstein
    Sao Paulo, SP 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

Showing the first 100 of 140 sites across 17 countries.

07

References and documents

Publications

  • 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. PubMed 17452677 ↗
  • 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. PubMed 26808546 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00040183
Lead sponsor
OSI Pharmaceuticals
Collaborators
Canadian Cancer Trials Group
Responsible party
Sponsor
First posted
Jun 25, 2002
Start date
Nov 29, 2001
Primary completion
Jan 15, 2004
Completion
Jan 15, 2004
Last update
Jan 10, 2018
View the source record on ClinicalTrials.gov ↗

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