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

NCT00035035 | Completed Phase 3

• 2 other identifiers: 5148H3E-MC-JMES
• Study Type: interventional
• Target: N/A
• Locations: 17 countries
• Sites: 111

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.

Conditions

Pancreatic Neoplasms; Metastases, Neoplasm

Keywords

Pancreas; Cancer; Unresectable or Metastatic Cancer of the Pancreas; Alimta

Interventions

GEMZAR DRUG

ALIMTA DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (114)

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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, 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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MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis; Neoplasms

Interventions

Gemcitabine; Pemetrexed

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2002
• First Posted: May 3, 2002
• Last Updated: July 19, 2006

Record last verified: 2006-07

Locations

AU (6); US (40); IT (3); PE (2); AR (4); NL (5); GR (2); GB (6); CO (1); FR (7); ES (5); BE (3); DE (11); PT (4); TW (4); VE (3); SE (5)