ALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.

This study has been completed.

First Received: January 10, 2003 Last Updated: July 18, 2006 History of Changes

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00051493

Purpose

The purpose of this study is to evaluate the effects (good and bad) of LY231514 (ALIMTA) and Carboplatin on you and your non-small cell lung cancer.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: ALIMTA Drug: Carboplatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	ALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Estimated Enrollment:	50
Study Start Date:	April 2002
Estimated Study Completion Date:	December 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

You have a diagnosis of non-small cell lung cancer.
You have received no prior chemotherapy.
You have at least one measurable lesion.
You have an adequate performance status.
You are at least 18 years of age.

Exclusion Criteria:

You have previously received chemotherapy for your lung cancer.
You have received radiation within the last 30 days.
You have active infection or other serious condition.
You have brain metastasis.
You have recently lost a significant amount of weight.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051493

Locations

United States, Texas

Houston, Texas, United States

Sponsors and Collaborators

Eli Lilly and Company

More Information

No publications provided

Study ID Numbers:	6142, H3E-MC-JMEZ
Study First Received:	January 10, 2003
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00051493 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Non-Small Cell Lung Cancer
Lung Cancer
NSCLC
Advanced Non-Small Cell Lung Cancer

Additional relevant MeSH terms:

Antimetabolites
Thoracic Neoplasms
Respiratory Tract Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Carboplatin
Folic Acid Antagonists
Pharmacologic Actions

Carcinoma
Pemetrexed
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009