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

Not Applicable

• Conditions: -C259 Pancreas, unspecified; Pancreas, unspecified; C259

• Registration Number: PER-030-02
• Lead Sponsor: ELI LILLY INTERAMERICA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-03-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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: Not specified