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

Lilly

Status and phase

Completed

Phase 3

Conditions

Metastases, Neoplasm

Pancreatic Neoplasms

Treatments

Drug: ALIMTA

Drug: GEMZAR

Study type

Interventional

Funder types

Industry

Identifiers

NCT00035035

H3E-MC-JMES

5148

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.