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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
N/A
Not Enrolling
Both
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:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

PA.3

NCT ID:

NCT00040183

Start Date:

October 2001

Completion Date:

September 2004

Related Keywords:

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

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
University Hospitals of ClevelandCleveland, Ohio  44106
Green Mountain Oncology GroupRutland, Vermont  05701
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Baystate Medical CenterSpringfield, Massachusetts  01199
Southwest Regional Cancer CenterAustin, Texas  78705
New Britain General HospitalNew Britain, Connecticut  06050
Florida Cancer SpecialistsFort Myers, Florida  33901
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Carle Cancer CenterUrbana, Illinois  61801
Arena Oncology AssociatesGreat Neck, New York  11021
University of MinnesotaMinneapolis, Minnesota  55455
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Arizona Clinical Research CenterTucson, Arizona  85712
Loma Linda University Cancer InstituteLoma Linda, California  92354
Highlands Oncology GroupSpringdale, Arkansas  72764
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
Southwest Washington Medical CenterVancouver, Washington  98664
Annapolis Medical SpecialistsAnnapolis, Maryland  21401
New Hampshire Oncology-Hematology PAHooksett, New Hampshire  03106
Oncology of WisconsinGlendale, Wisconsin  53212
UCLA Medical CenterLos Angeles, California  90095-7059
Sarah Cannon Cancer CenterNashville, Tennessee  37203
Kaiser PermanenteSacramento, California  
New England Medical CenterBoston, Massachusetts  
Metropolitan Hematology/Oncology Medical Group, Inc.Los Angeles, California  90057
DeQuattro Community Cancer CenterManchester, Connecticut  06040
Eastern Connecticut OncologyNorwich, Connecticut  06360-2910
Carl and Dorothy Bennett Cancer CenterStamford, Connecticut  06902-3628
Oncology Hematology Group of South FloridaMiami, Florida  33176
Ocala OncologyOcala, Florida  34474
Tampa General HospitalTampa, Florida  33606
Atlanta Cancer CenterAtlanta, Georgia  30342
Onc/Hem Associates of Central IllinoisPeoria, Illinois  61602
Hematology Oncology Associates of IllinoisSkokie, Illinois  60077
University of Iowa Hospital & ClinicsIowa City, Iowa  52242
University of KentuckyLexington, Kentucky  40536-0098
Norton Healthcare, Inc.Louisville, Kentucky  40202
J Gurtler, Hematology and OncologyMetairie, Louisiana  70006
Sinai HospitalBaltimore, Maryland  21215
The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231
St Elizabeth Medical CenterBoston, Massachusetts  01235
Berkshire Hematology & Oncology, PCPittsfield, Massachusetts  012018298
Kansas City Oncology and Hematology GroupKansas City, Missouri  64111
St Barnabas Medical CenterLivingston, New Jersey  07039
New York University School of MedicineNew York, New York  10016
St Luke's-Roosevelt HospitalNew York, New York  10019
Interlakes Oncology & Hematology, P.C.Rochester, New York  14623
Stony Brook University HospitalStony Brook, New York  11794-8174
Odyssey Research ServicesBismarck, North Dakota  58501
Chiles Research Cancer CenterPortland, Oregon  97213-2967
Hematology & Oncolgy Assoc of NE PADunmore, Pennsylvania  18512
Charleston Hematology/OncologyCharleston, South Carolina  29403
Arlington Cancer CentreArlington, Texas  76012
Tyler Hematology Oncology PATyler, Texas  75701
Hematology & Oncology Associates of Virginia, Ltd.Richmond, Virginia  23226
Western Washington Oncology Inc.Olympia, Washington  98502