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

Completed · Phase 3

Conditions studied: Pancreatic Neoplasms, Metastases, Neoplasm

In brief

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.

Key facts

Study ID

NCT00035035

Run by

Eli Lilly and Company

Last updated by the study team

2006-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Fountain Valley, California, United States
• Study site — Fullerton, California, United States
• Study site — Lancaster, California, United States
• Study site — Los Angeles, California, United States
• Study site — Pomona, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Torrance, California, United States
• Study site — Fort Collins, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Lake Worth, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Decatur, Illinois, United States
• Study site — Harvey, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Crestview Hills, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Lafayette, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Scarborough, Maine, United States
• Study site — Burlington, Massachusetts, United States
• Study site — Omaha, Nebraska, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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