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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.


Phase 3
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasms, Metastases, Neoplasm

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

5148

NCT ID:

NCT00035035

Start Date:

Completion Date:

Related Keywords:

  • Pancreatic Neoplasms
  • Metastases, Neoplasm
  • Pancreas
  • Cancer
  • Unresectable or Metastatic Cancer of the Pancreas
  • Alimta
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Pancreatic Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Louisville, Kentucky  40207
Kansas City, Kansas  66160
Scarborough, Maine  04074
Omaha, Nebraska  68114
Albuquerque, New Mexico  87131-5636
Metairie, Louisiana  70006
Denver, Colorado  
Boston, Massachusetts  
Milwaukee, Wisconsin  
Indianapolis, Indiana  
Charleston, South Carolina