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

Phase 3

Completed

• Conditions: Pancreatic Neoplasms; Metastases, Neoplasm

• Registration Number: NCT00035035
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-05-02
• Study First Submitted QC: 2002-05-02
• Study First Posted: 2002-05-03
• Status Verified: 2006-07
• Last Update Submitted: 2006-07-18
• Last Update Posted: 2006-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL