Comparing 3 Schedules of Alimta Plus Gemzar

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00034606

First received: May 1, 2002

Last updated: July 18, 2006

Last verified: July 2006

History of Changes

Purpose

The purpose of the study is to measure tumor response rates for three schedules of Alimta(LY231514) in combination with gemcitabine in patients with locally advanced or metastatic non small cell lung cancer who have received no prior chemotherapy regimen.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms	Drug: Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

Drug Information available for: 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:

Diagnosis of non-small lung cancer
No prior chemotherapy
Able to care for self

Exclusion Criteria:

An ongoing infection
Pregnancy or breast feeding
Other serious medical condition
Cancer that has spread to the brain
Inability to take folic acid

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: NCT00034606

Locations


United States, Minnesota

Rochester, Minnesota, United States

Sponsors and Collaborators

Eli Lilly and Company

More Information


ClinicalTrials.gov Identifier:	NCT00034606 History of Changes
Other Study ID Numbers:	5115 H3E-MC-JMEL
Study First Received:	May 1, 2002
Last Updated:	July 18, 2006

Keywords provided by Eli Lilly and Company:


Lung cancer cancer neoplasm non-small chemotherapy

Additional relevant MeSH terms:


Neoplasms Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Gemcitabine Pemetrexed	Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on June 23, 2017

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