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

July 18, 2006 updated 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 2, 2002

First Submitted That Met QC Criteria

May 2, 2002

First Posted (Estimate)

May 3, 2002

Study Record Updates

Last Update Posted (Estimate)

July 19, 2006

Last Update Submitted That Met QC Criteria

July 18, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5148
  • H3E-MC-JMES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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