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A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.

Primary Purpose

Pancreatic Neoplasms, Metastases, Neoplasm

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GEMZAR
ALIMTA
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Pancreas, Cancer, Unresectable or Metastatic Cancer of the Pancreas, Alimta

Eligibility Criteria

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

Inclusion Criteria: Pancreas cancer that cannot be removed by surgery OR that has spread to a new site in your body. You must have one tumor that can be physically measured or scanned by the doctor. You have not had any chemotherapy, immunotherapy, biologic therapy, or hormonal therapy for pancreas cancer, including 5-FU. You cannot have any radiation for 4 weeks before starting this study, and you cannot have radiation to the whole pelvis. Exclusion Criteria: Treatment with any medication or device that has not been approved by regulatory agencies, like the FDA, at the time you enter the study. Documentation that the cancer has spread to your brain. Pregnant or breastfeeding. A second primary cancer. Unable to stop aspirin or non-steroidal anti-inflammatory agents (like ibuprofen) for 5-8 days.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2002
Last Updated
July 18, 2006
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00035035
Brief Title
A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.
Official Title
A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA for the treatment of cancer of the pancreas. Patients may be able to participate in this study if they have cancer in their pancreas that cannot be removed by surgery OR that has spread to a new site in their body.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms, Metastases, Neoplasm
Keywords
Pancreas, Cancer, Unresectable or Metastatic Cancer of the Pancreas, Alimta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GEMZAR
Intervention Type
Drug
Intervention Name(s)
ALIMTA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pancreas cancer that cannot be removed by surgery OR that has spread to a new site in your body. You must have one tumor that can be physically measured or scanned by the doctor. You have not had any chemotherapy, immunotherapy, biologic therapy, or hormonal therapy for pancreas cancer, including 5-FU. You cannot have any radiation for 4 weeks before starting this study, and you cannot have radiation to the whole pelvis. Exclusion Criteria: Treatment with any medication or device that has not been approved by regulatory agencies, like the FDA, at the time you enter the study. Documentation that the cancer has spread to your brain. Pregnant or breastfeeding. A second primary cancer. Unable to stop aspirin or non-steroidal anti-inflammatory agents (like ibuprofen) for 5-8 days.
Facility Information:
City
Huntsville
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Alabama
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United States
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Fountain Valley
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California
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United States
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Fullerton
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United States
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Lancaster
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United States
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Los Angeles
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Pomona
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Santa Rosa
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United States
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Torrance
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Fort Collins
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Colorado
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Hartford
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Connecticut
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Lake Worth
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Miami
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Chicago
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Illinois
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Decatur
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Illinois
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Harvey
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Illinois
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Indianapolis
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Indiana
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United States
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Wichita
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Kansas
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United States
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Crestview Hills
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Kentucky
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United States
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Louisville
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Kentucky
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Lafayette
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Louisiana
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Shreveport
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Louisiana
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Scarborough
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Maine
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Burlington
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Massachusetts
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Omaha
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Nebraska
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United States
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Albuquerque
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New Mexico
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United States
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New York
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New York
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United States
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Canton
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Ohio
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United States
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Cleveland
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Ohio
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United States
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Drexel Hill
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Pennsylvania
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United States
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Pittsburgh
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Charleston
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South Carolina
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United States
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Columbia
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Johnson City
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United States
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Memphis
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Nashville
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San Antonio
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United States
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Tyler
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Tacoma
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United States
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Marshfield
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United States
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Milwaukee
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Wisconsin
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Capitol Federal
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Buenos Aires
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Argentina
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Santa Fe
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Rosario
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Argentina
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Ciudad De Buenos Aires
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Argentina
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Mendoza
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Argentina
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Bankstown
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New South Wales
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Australia
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Kingswood Penrith
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New South Wales
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Australia
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Wollongong
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New South Wales
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Australia
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Southport
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Queensland
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Australia
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Fitzroy
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Victoria
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Australia
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Frankston
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Victoria
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Australia
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Innsbruck
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Austria
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St. Veit Glan
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Austria
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Wien
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Austria
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Brussels
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Cali
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Colombia
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Strasbourg
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Cedex
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France
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Lille Cedex
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France
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Marseille
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France
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Paris Cedex 10
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France
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Paris Cedex 13
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France
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Rennes Cedex
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France
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Rouen Cedex
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France
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Toulouse Cedex
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France
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Bielefeld
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Nordhein-Westfalen
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Germany
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Berlin
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Germany
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Bremerhaven
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Germany
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Frankfurt
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Germany
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Kaiserslautern
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Germany
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Karlsruhe
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Germany
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Magdeburg
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Germany
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Mannheim
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Germany
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Munchen
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Germany
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Neustadt/Suedharz
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Germany
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Stuttgart
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Germany
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Maroussi
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Athens
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Greece
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Ioannina
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Greece
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Genova
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Italy
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Ravenna
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Italy
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Roma
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Italy
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Breda
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Netherlands
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Den Haag
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Netherlands
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Enschede
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Netherlands
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Roermond
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Netherlands
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Sittard
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Netherlands
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Chiclayo
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Peru
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Lima
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Peru
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Lisboa
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Portugal
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Porto
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Portugal
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Santa Maria Da Feira
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Portugal
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Santarem
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Portugal
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Elche
State/Province
Alicante
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Santa Cruz De Tenerife
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Spain
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Zaragoza
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Spain
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Linkoping
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Sweden
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Lund
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Sweden
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Malmo
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Sweden
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Stockholm
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Sweden
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Umea
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Sweden
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Tao-Yuan
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Kuei-Shan
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Taiwan
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Yungkang City
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Tainan
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Bristol
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Avon
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United Kingdom
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Hull
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East Yorkshire
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United Kingdom
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Acton
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London
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United Kingdom
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Northwood
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Middlesex
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United Kingdom
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Belfast
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Northern Ireland
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United Kingdom
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Manchester
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United Kingdom
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Valencia
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Edo. Aragua
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Venezuela
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Estado Aragua
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Maracay
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Venezuela
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Caracas
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Venezuela

12. IPD Sharing Statement

Learn more about this trial

A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.

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