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

Condition(s) targeted: Pancreatic Neoplasms; Metastases, Neoplasm

Intervention: GEMZAR (Drug); ALIMTA (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Ciudad De Buenos Aires, Argentina

Mendoza, Argentina

Wien, Austria

St. Veit Glan, Austria

Innsbruck, Austria

Leuven, Belgium

Brussels, Belgium

Gent, Belgium

Cali, Colombia

Lille Cedex, France

Paris Cedex 13, France

Marseille, France

Toulouse Cedex, France

Paris Cedex 10, France

Rouen Cedex, France

Rennes Cedex, France

Kaiserslautern, Germany

Berlin, Germany

Magdeburg, Germany

Munchen, Germany

Karlsruhe, Germany

Stuttgart, Germany

Neustadt/Suedharz, Germany

Mannheim, Germany

Bremerhaven, Germany

Frankfurt, Germany

Ioannina, Greece

Ravenna, Italy

Roma, Italy

Genova, Italy

Den Haag, Netherlands

Sittard, Netherlands

Breda, Netherlands

Enschede, Netherlands

Roermond, Netherlands

Lima, Peru

Chiclayo, Peru

Porto, Portugal

Santa Maria Da Feira, Portugal

Santarem, Portugal

Lisboa, Portugal

Barcelona, Spain

Madrid, Spain

Santa Cruz De Tenerife, Spain

Zaragoza, Spain

Malmo, Sweden

Lund, Sweden

Linkoping, Sweden

Stockholm, Sweden

Umea, Sweden

Taipei, Taiwan

Tainan, Taiwan

Manchester, United Kingdom

Caracas, Venezuela

Huntsville, Alabama, United States

Elche, Alicante, Spain

Maroussi, Athens, Greece

Bristol, Avon, United Kingdom

Capitol Federal, Buenos Aires, Argentina

Fountain Valley, California, United States

Fullerton, California, United States

Los Angeles, California, United States

Torrance, California, United States

Lancaster, California, United States

Santa Rosa, California, United States

Pomona, California, United States

Strasbourg, Cedex, France

Fort Collins, Colorado, United States

Hartford, Connecticut, United States

Hull, East Yorkshire, United Kingdom

Valencia, Edo. Aragua, Venezuela

Lake Worth, Florida, United States

Miami, Florida, United States

Harvey, Illinois, United States

Decatur, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Wichita, Kansas, United States

Louisville, Kentucky, United States

Crestview Hills, Kentucky, United States

Tao-Yuan, Kuei-Shan, Taiwan

Acton, London, United Kingdom

Lafayette, Louisiana, United States

Shreveport, Louisiana, United States

Scarborough, Maine, United States

Estado Aragua, Maracay, Venezuela

Burlington, Massachusetts, United States

Northwood, Middlesex, United Kingdom

Omaha, Nebraska, United States

Albuquerque, New Mexico, United States

Bankstown, New South Wales, Australia

Kingswood Penrith, New South Wales, Australia

Wollongong, New South Wales, Australia

New York, New York, United States

Bielefeld, Nordhein-Westfalen, Germany

Belfast, Northern Ireland, United Kingdom

Cleveland, Ohio, United States

Canton, Ohio, United States

Pittsburgh, Pennsylvania, United States

Drexel Hill, Pennsylvania, United States

Southport, Queensland, Australia

Santa Fe, Rosario, Argentina

Charleston, South Carolina, United States

Columbia, South Carolina, United States

Yungkang City, Tainan, Taiwan

Memphis, Tennessee, United States

Nashville, Tennessee, United States

Johnson City, Tennessee, United States

Tyler, Texas, United States

San Antonio, Texas, United States

Fitzroy, Victoria, Australia

Frankston, Victoria, Australia

Tacoma, Washington, United States

Marshfield, Wisconsin, United States

Milwaukee, Wisconsin, United States

Last updated: July 18, 2006