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

Phase 3
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

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

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.'

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

October 2001

Completion Date:

September 2004

Related Keywords:

  • Pancreatic Cancer
  • Tarceva, EGFR, erlotinib, OSI-774
  • Pancreatic Neoplasms



MD Anderson Cancer Center Houston, Texas  77030-4096
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
University Hospitals of Cleveland Cleveland, Ohio  44106
Green Mountain Oncology Group Rutland, Vermont  05701
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Baystate Medical Center Springfield, Massachusetts  01199
Southwest Regional Cancer Center Austin, Texas  78705
New Britain General Hospital New Britain, Connecticut  06050
Florida Cancer Specialists Fort Myers, Florida  33901
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
Carle Cancer Center Urbana, Illinois  61801
Arena Oncology Associates Great Neck, New York  11021
University of Minnesota Minneapolis, Minnesota  55455
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Arizona Clinical Research Center Tucson, Arizona  85712
Loma Linda University Cancer Institute Loma Linda, California  92354
Highlands Oncology Group Springdale, Arkansas  72764
Pennsylvania Oncology Hematology Associates Philadelphia, Pennsylvania  19107
Southwest Washington Medical Center Vancouver, Washington  98664
Annapolis Medical Specialists Annapolis, Maryland  21401
New Hampshire Oncology-Hematology PA Hooksett, New Hampshire  03106
Oncology of Wisconsin Glendale, Wisconsin  53212
UCLA Medical Center Los Angeles, California  90095-7059
Sarah Cannon Cancer Center Nashville, Tennessee  37203
Kaiser Permanente Sacramento, California  
New England Medical Center Boston, Massachusetts  
Metropolitan Hematology/Oncology Medical Group, Inc. Los Angeles, California  90057
DeQuattro Community Cancer Center Manchester, Connecticut  06040
Eastern Connecticut Oncology Norwich, Connecticut  06360-2910
Carl and Dorothy Bennett Cancer Center Stamford, Connecticut  06902-3628
Oncology Hematology Group of South Florida Miami, Florida  33176
Ocala Oncology Ocala, Florida  34474
Tampa General Hospital Tampa, Florida  33606
Atlanta Cancer Center Atlanta, Georgia  30342
Onc/Hem Associates of Central Illinois Peoria, Illinois  61602
Hematology Oncology Associates of Illinois Skokie, Illinois  60077
University of Iowa Hospital & Clinics Iowa City, Iowa  52242
University of Kentucky Lexington, Kentucky  40536-0098
Norton Healthcare, Inc. Louisville, Kentucky  40202
J Gurtler, Hematology and Oncology Metairie, Louisiana  70006
Sinai Hospital Baltimore, Maryland  21215
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231
St Elizabeth Medical Center Boston, Massachusetts  01235
Berkshire Hematology & Oncology, PC Pittsfield, Massachusetts  012018298
Kansas City Oncology and Hematology Group Kansas City, Missouri  64111
St Barnabas Medical Center Livingston, New Jersey  07039
New York University School of Medicine New York, New York  10016
St Luke's-Roosevelt Hospital New York, New York  10019
Interlakes Oncology & Hematology, P.C. Rochester, New York  14623
Stony Brook University Hospital Stony Brook, New York  11794-8174
Odyssey Research Services Bismarck, North Dakota  58501
Chiles Research Cancer Center Portland, Oregon  97213-2967
Hematology & Oncolgy Assoc of NE PA Dunmore, Pennsylvania  18512
Charleston Hematology/Oncology Charleston, South Carolina  29403
Arlington Cancer Centre Arlington, Texas  76012
Tyler Hematology Oncology PA Tyler, Texas  75701
Hematology & Oncology Associates of Virginia, Ltd. Richmond, Virginia  23226
Western Washington Oncology Inc. Olympia, Washington  98502