Alimta, Carboplatin and Radiation Therapy for Non Small Cell Lung Cancer

This study is currently recruiting participants.

Verified by Thomas Jefferson University, April 2007

Sponsors and Collaborators:	Thomas Jefferson University Eli Lilly and Company
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00330044

Purpose

To determine the safety of Alimta when used with chemoradiation in inoperable non small cell lung cancer

Condition	Intervention	Phase
Inoperable Non Small Cell Lung Cancer	Drug: Premetrexed (Alimta)	Phase I

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Study of Premetrexed (Alimta) and Carboplatin and Radiation Therapy in Patients With Inoperable Non Small Cell Lung Cancer.

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

Response and Progression Free Survival

Estimated Enrollment:	27
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2009

Detailed Description:

To determine the maximal tolerated dose (MTD) and toxicities of Pemetrexed (Alimta) when administered concurrently with carboplatin and thoracic radiation therapy.

To determine, qualitatively, the occurrence of local tumor responses identified with this regimen.

Eligibility

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

Criteria

Inclusion Criteria:

Unresectable Stage II, IIIB or IV non small cell lung cancer. Evaluable disease on planning CT scan Zubrod 0-1 Weight loss equal to or less than 10% 3 months prior to diagnosis FEV1 greater than 1000cc Adequate hematologic, renal and hepatic functions

Exclusion Criteria:

Small cell cancer Stage I non small cell cancer Prior chemotherapy or thoracic or lower neck radiatio therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330044

Contacts

Contact: Mitchell Machtay, MD	215-955-6706	mitchell.machtay@mail.tju.edu
Contact: Gayle Mallon, CCRP	215-955-8619	gayle.mallon@mail.tju.edu

Locations

United States, Pennsylvania
Thomas Jefferson University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Mitchell Machtay, MD 215-955-6706 mitchell.machtay@mail.tju.edu
Contact: Rita Axelrod, MD 215-955-8874 rita.axelrod@jefferson.edu
Principal Investigator: Mitchell Machtay, MD

Sponsors and Collaborators

Thomas Jefferson University

Eli Lilly and Company

Investigators

Principal Investigator:

Mitchell Machtay, MD

Thomas Jefferson University

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	05C.276
Study First Received:	May 24, 2006
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00330044
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carboplatin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009