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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.
This study has been completed.
First Received: May 2, 2002   Last Updated: July 18, 2006   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00035035
  Purpose

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.


Condition Intervention Phase
Pancreatic Neoplasms
Metastases, Neoplasm
 Drug: GEMZAR
Drug: ALIMTA
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Pancrelipase Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium Ultrase
U.S. FDA Resources
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035035

  Hide Study Locations
Locations
United States, Alabama
Huntsville, Alabama, United States
United States, California
Fountain Valley, California, United States
Fullerton, California, United States
Santa Rosa, California, United States
Torrance, California, United States
Lancaster, California, United States
Los Angeles, California, United States
Pomona, California, United States
United States, Colorado
Fort Collins, Colorado, United States
United States, Connecticut
Hartford, Connecticut, United States
United States, Florida
Lake Worth, Florida, United States
Miami, Florida, United States
United States, Illinois
Harvey, Illinois, United States
Decatur, Illinois, United States
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Wichita, Kansas, United States
United States, Kentucky
Louisville, Kentucky, United States
Crestview Hills, Kentucky, United States
United States, Louisiana
Lafayette, Louisiana, United States
Shreveport, Louisiana, United States
United States, Maine
Scarborough, Maine, United States
United States, Massachusetts
Burlington, Massachusetts, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
New York, New York, United States
United States, Ohio
Cleveland, Ohio, United States
Canton, Ohio, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
Drexel Hill, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Columbia, South Carolina, United States
United States, Tennessee
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Johnson City, Tennessee, United States
United States, Texas
Tyler, Texas, United States
San Antonio, Texas, United States
United States, Washington
Tacoma, Washington, United States
United States, Wisconsin
Marshfield, Wisconsin, United States
Milwaukee, Wisconsin, United States
Argentina
Ciudad De Buenos Aires, Argentina
Mendoza, Argentina
Argentina, Buenos Aires
Capitol Federal, Buenos Aires, Argentina
Argentina, Rosario
Santa Fe, Rosario, Argentina
Australia, New South Wales
Bankstown, New South Wales, Australia
Kingswood Penrith, New South Wales, Australia
Wollongong, New South Wales, Australia
Australia, Queensland
Southport, Queensland, Australia
Australia, Victoria
Fitzroy, Victoria, Australia
Frankston, Victoria, Australia
Austria
Wien, Austria
St. Veit Glan, Austria
Innsbruck, Austria
Belgium
Leuven, Belgium
Brussels, Belgium
Gent, Belgium
Colombia
Cali, Colombia
France
Lille Cedex, France
Paris Cedex 13, France
Marseille, France
Toulouse Cedex, France
Paris Cedex 10, France
Rouen Cedex, France
Rennes Cedex, France
France, Cedex
Strasbourg, Cedex, France
Germany
Neustadt/Suedharz, Germany
Berlin, Germany
Magdeburg, Germany
Munchen, Germany
Karlsruhe, Germany
Stuttgart, Germany
Kaiserslautern, Germany
Mannheim, Germany
Bremerhaven, Germany
Frankfurt, Germany
Germany, Nordhein-Westfalen
Bielefeld, Nordhein-Westfalen, Germany
Greece
Ioannina, Greece
Greece, Athens
Maroussi, Athens, Greece
Italy
Ravenna, Italy
Roma, Italy
Genova, Italy
Netherlands
Den Haag, Netherlands
Sittard, Netherlands
Roermond, Netherlands
Enschede, Netherlands
Breda, Netherlands
Peru
Lima, Peru
Chiclayo, Peru
Portugal
Porto, Portugal
Santa Maria Da Feira, Portugal
Santarem, Portugal
Lisboa, Portugal
Spain
Barcelona, Spain
Madrid, Spain
Santa Cruz De Tenerife, Spain
Zaragoza, Spain
Spain, Alicante
Elche, Alicante, Spain
Sweden
Malmo, Sweden
Stockholm, Sweden
Linkoping, Sweden
Lund, Sweden
Umea, Sweden
Taiwan
Taipei, Taiwan
Tainan, Taiwan
Taiwan, Kuei-Shan
Tao-Yuan, Kuei-Shan, Taiwan
Taiwan, Tainan
Yungkang City, Tainan, Taiwan
United Kingdom
Manchester, United Kingdom
United Kingdom, Avon
Bristol, Avon, United Kingdom
United Kingdom, East Yorkshire
Hull, East Yorkshire, United Kingdom
United Kingdom, London
Acton, London, United Kingdom
United Kingdom, Middlesex
Northwood, Middlesex, United Kingdom
United Kingdom, Northern Ireland
Belfast, Northern Ireland, United Kingdom
Venezuela
Caracas, Venezuela
Venezuela, Edo. Aragua
Valencia, Edo. Aragua, Venezuela
Venezuela, Maracay
Estado Aragua, Maracay, Venezuela
Sponsors and Collaborators
Eli Lilly and Company
  More Information

No publications provided

Study ID Numbers: 5148, H3E-MC-JMES
Study First Received: May 2, 2002
Last Updated: July 18, 2006
ClinicalTrials.gov Identifier: NCT00035035     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Pancreas
Cancer
Unresectable or Metastatic Cancer of the Pancreas
Alimta

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Pancrelipase
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Gemcitabine
 Endocrine Gland Neoplasms
Digestive System Neoplasms
Gastrointestinal Agents
Endocrine System Diseases
Enzyme Inhibitors
Folic Acid Antagonists
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Pemetrexed
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 27, 2009



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