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

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00035035

First received: May 2, 2002

Last updated: July 18, 2006

Last verified: July 2006

History of Changes

Purpose

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.

Condition	Intervention	Phase
Pancreatic Neoplasms Metastases, Neoplasm	Drug: GEMZAR Drug: ALIMTA	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.

Resource links provided by NLM:

MedlinePlus related topics: Pancreatic Cancer

Drug Information available for: Pancreatin Pancrelipase Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035035

Show 115 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

More Information


ClinicalTrials.gov Identifier:	NCT00035035 History of Changes
Obsolete Identifiers:	NCT00049426
Other Study ID Numbers:	5148 H3E-MC-JMES
Study First Received:	May 2, 2002
Last Updated:	July 18, 2006

Keywords provided by Eli Lilly and Company:


Pancreas Cancer Unresectable or Metastatic Cancer of the Pancreas Alimta

Additional relevant MeSH terms:


Neoplasms Neoplasm Metastasis Pancreatic Neoplasms Neoplastic Processes Pathologic Processes Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Pemetrexed Pancrelipase	Pancreatin Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Gastrointestinal Agents Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017

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