Skip to main content
OpenTrials
Completed

NCT Number: NCT00035035

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Metastases, Neoplasm Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Capitol Federal, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemzar

Drug

Alimta

Drug

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Important dates

First posted
May 3, 2002
Registry last updated
Jul 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.