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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tarceva (erlotinib HCl, OSI-774)
Sponsored by
OSI Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Tarceva, EGFR, erlotinib, OSI-774

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.'

Sites / Locations

  • Arizona Clinical Research Center
  • Highlands Oncology Group
  • Alta Bates Comprehensive Cancer Center
  • Loma Linda University Cancer Institute
  • Metropolitan Hematology/Oncology Medical Group, Inc.
  • UCLA Medical Center
  • Kaiser Permanente
  • DeQuattro Community Cancer Center
  • New Britain General Hospital
  • Eastern Connecticut Oncology
  • Carl and Dorothy Bennett Cancer Center
  • Florida Cancer Specialists
  • Oncology Hematology Group of South Florida
  • Ocala Oncology
  • Tampa General Hospital
  • Atlanta Cancer Center
  • Onc/Hem Associates of Central Illinois
  • Hematology Oncology Associates of Illinois
  • Carle Cancer Center
  • University of Iowa Hospital & Clinics
  • University of Kansas Medical Center
  • University of Kentucky
  • Norton Healthcare, Inc.
  • Mary Bird Perkins Cancer Center
  • J Gurtler, Hematology and Oncology
  • Annapolis Medical Specialists
  • Sinai Hospital
  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • St Elizabeth Medical Center
  • New England Medical Center
  • Berkshire Hematology & Oncology, PC
  • Baystate Medical Center
  • University of Minnesota
  • Kansas City Oncology and Hematology Group
  • New Hampshire Oncology-Hematology PA
  • St Barnabas Medical Center
  • Arena Oncology Associates
  • New York University School of Medicine
  • St Luke's-Roosevelt Hospital
  • Interlakes Oncology & Hematology, P.C.
  • Stony Brook University Hospital
  • Presbyterian Hospital
  • Odyssey Research Services
  • University Hospitals of Cleveland
  • Chiles Research Cancer Center
  • Hematology & Oncolgy Assoc of NE PA
  • University of Pennsylvania Cancer Center
  • Pennsylvania Oncology Hematology Associates
  • Fox Chase Cancer Center
  • Charleston Hematology/Oncology
  • Sarah Cannon Cancer Center
  • Arlington Cancer Centre
  • Southwest Regional Cancer Center
  • MD Anderson Cancer Center
  • Tyler Hematology Oncology PA
  • Green Mountain Oncology Group
  • Hematology & Oncology Associates of Virginia, Ltd.
  • Western Washington Oncology Inc.
  • Southwest Washington Medical Center
  • Oncology of Wisconsin
  • Hospital Italiano de Buenos Aires
  • Hospital Britanico
  • Instituto Oncologico Angel Roffo
  • Instituto Alexander Fleming
  • Hospital Churruca Visca
  • Centro Medico Confidence
  • Concord Hospital
  • Newcastle Mater Hospital
  • Prince of Wales Hospital
  • Royal Adelaide Hospital
  • Ashford Cancer Centre
  • The Queen Elizabeth Hospital
  • Frankston Hospital
  • Austin & Repatriation Medical Centre
  • Institute Jules Bordet
  • Nucleo de Oncolgia da Bahia
  • Hospital Vera Cruz S/A
  • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Hospital Israelita Albert Einstein
  • Cross Cancer Institute
  • BC Cancer Centre for the Southern Interior
  • Pentincton Regional Hospital
  • Fraser Valley Cancer Centre
  • BCCA VAncouver Centre
  • BCCA- Vancouver Island Centre
  • CancerCare Manitoba (CCMB)
  • Saint John Regional Hospital
  • Dr. H. Bliss Murphy Cancer Centre
  • QEII Health Sciences Centre
  • Hamilton Regional Cancer Centre
  • Kingston Regional Cancer Centre
  • London Regional Cancer Center
  • Credit Valley Hospital
  • Ottawa Regional Cancer Centre
  • Group Health Centre
  • Hotel Dieu Health Sciences HospitalNiagra
  • Toronto East General Hospital
  • Toronto-Sunnybrook Regional Cancer Center
  • Princess Margaret Hospital
  • St Joseph's Health Centre
  • Hopital Maisonneuve-Rosemont
  • Hopital Du Sacre-Coeur
  • Hopital Laval
  • Allan Blair Cancer Centre
  • Clinica Las Condes
  • Charite Campus Virchow Klinikum
  • Universitatsklinikum Essen
  • Tumor Biology Center
  • Universitatskliniken des Saarlands Innere Medizin II
  • Innere MedizinUniversitatsklinikum Heidelberg
  • Universitatskliniken des Saarlands
  • Medizinische Poliklinik der Universitaet Wurzburg
  • Anticancer Hospital of Thessaloniki "THEAGENIO"
  • District General Hospital of Thessaloniki "HIPPOKRATION"
  • Rambam Medical Center
  • Rabin Medical Center (Belinson Campus)
  • Kaplan Medical Center
  • Sourasky Medical Center (Ichikov)
  • Chaim Sheba Medical Center
  • Azienda Ospedaliera Universitaria Policlinico A.O.V.P. Oncologia Medica
  • Instituto Nacional De Cancerologia
  • Auckland Hospital
  • Christchurch HospitalClinical Oncology Hospital
  • Great Poland Cancer Centre
  • Dolnoslaskie Centrum Onkologii
  • Oncology Institute Ion Chiricuta
  • St. Spiridon University Hospital
  • Clinical County Hospital Sibiu
  • National University Hospital
  • Singapore General Hospital
  • National Cancer Centre
  • ICRF Medical Oncology Unit
  • Velindre Hospital
  • Russell's Hall HospitalDepartment of OncologyGeorgina Unit
  • Deanesly Centre
  • The Princess Royal Hospital
  • St. Bartholomews Hospital
  • North Middlesex Hospital
  • Department of Medical Oncology
  • Newcastle General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 21, 2002
Last Updated
January 8, 2018
Sponsor
OSI Pharmaceuticals
Collaborators
Canadian Cancer Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00040183
Brief Title
OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.
Official Title
A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 29, 2001 (Actual)
Primary Completion Date
January 15, 2004 (Actual)
Study Completion Date
January 15, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OSI Pharmaceuticals
Collaborators
Canadian Cancer Trials Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Tarceva, EGFR, erlotinib, OSI-774

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
569 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tarceva (erlotinib HCl, OSI-774)

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
17452677
Citation
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.
Results Reference
background
PubMed Identifier
26808546
Citation
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.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=62
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

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

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