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

NCT ID: NCT00035035

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Neoplasms Metastases, Neoplasm

Keywords

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Pancreas Cancer Unresectable or Metastatic Cancer of the Pancreas Alimta

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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GEMZAR

Intervention Type DRUG

ALIMTA

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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Huntsville, Alabama, United States

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Fountain Valley, California, United States

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Fullerton, California, United States

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Lancaster, California, United States

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Los Angeles, California, United States

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Pomona, California, United States

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Santa Rosa, California, United States

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Torrance, California, United States

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Fort Collins, Colorado, United States

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Hartford, Connecticut, United States

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Lake Worth, Florida, United States

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Miami, Florida, United States

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Chicago, Illinois, United States

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Decatur, Illinois, United States

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Harvey, Illinois, United States

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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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Crestview Hills, Kentucky, United States

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Louisville, Kentucky, United States

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Lafayette, Louisiana, United States

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Shreveport, Louisiana, United States

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Scarborough, Maine, United States

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Burlington, Massachusetts, United States

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Omaha, Nebraska, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Canton, Ohio, United States

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Cleveland, Ohio, United States

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Drexel Hill, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Johnson City, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Tacoma, Washington, United States

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Marshfield, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Capitol Federal, Buenos Aires, Argentina

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Mendoza, Mendoza Province, Argentina

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Santa Fe, Rosario, Argentina

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Ciudad de Buenos Aires, , Argentina

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Bankstown, New South Wales, Australia

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Kingswood Penrith, New South Wales, Australia

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Wollongong, New South Wales, Australia

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Southport, Queensland, Australia

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Fitzroy, Victoria, Australia

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Frankston, Victoria, Australia

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Innsbruck, , Austria

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Saint Veit Glan, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Cali, , Colombia

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Strasbourg, Cedex, France

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Lille, , France

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Marseille, , France

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Paris, , France

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Rennes, , France

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Rouen, , France

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Toulouse, , France

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Bielefeld, Nordhein-Westfalen, Germany

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Berlin, , Germany

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Bremerhaven, , Germany

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Frankfurt, , Germany

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Kaiserslautern, , Germany

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Karlsruhe, , Germany

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Magdeburg, , Germany

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Mannheim, , Germany

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München, , Germany

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Neustadt/Suedharz, , Germany

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Stuttgart, , Germany

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Marousi, Athens, Greece

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Ioannina, , Greece

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Genova, , Italy

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Ravenna, , Italy

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Roma, , Italy

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Breda, , Netherlands

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Enschede, , Netherlands

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Roermond, , Netherlands

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Sittard, , Netherlands

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The Hague, , Netherlands

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Chiclayo, , Peru

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Lima, , Peru

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Lisbon, , Portugal

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Porto, , Portugal

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Santa Maria da Feira, , Portugal

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Santarém, , Portugal

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Elche, Alicante, Spain

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Barcelona, Barcelona, Spain

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Madrid, Madrid, Spain

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Santa Cruz de Tenerife, Santa Cruz De Tenerife, Spain

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Zaragoza, Zaragoza, Spain

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Linköping, , Sweden

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Lund, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Umeå, , Sweden

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Taoyuan District, Kuei-Shan, Taiwan

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Yungkang City, Tainan, Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Bristol, Avon, United Kingdom

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Hull, East Yorkshire, United Kingdom

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Acton, London, United Kingdom

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Northwood, Middlesex, United Kingdom

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Belfast, Northern Ireland, United Kingdom

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Manchester, , United Kingdom

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Valencia, Edo. Aragua, Venezuela

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Estado Aragua, Maracay, Venezuela

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Caracas, , Venezuela

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Countries

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United States Argentina Australia Austria Belgium Colombia France Germany Greece Italy Netherlands Peru Portugal Spain Sweden Taiwan United Kingdom Venezuela

Other Identifiers

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H3E-MC-JMES

Identifier Type: -

Identifier Source: secondary_id

5148

Identifier Type: -

Identifier Source: org_study_id

NCT00049426

Identifier Type: -

Identifier Source: nct_alias