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

Inoperable Non Small Cell Lung Cancer Clinical Trial

Official title:

A Phase I Study of Premetrexed (Alimta) and Carboplatin and Radiation Therapy in Patients With Inoperable Non Small Cell Lung Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330044
• Other study ID #: 05C.276
• Secondary ID: 2005-19
• Status: Completed
• Phase: Phase 1
• First received: May 24, 2006
• Last updated: December 1, 2016
• Start date: April 2006
• Est. completion date: October 2009

Study information

• Verified date: December 2016
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Inoperable Non Small Cell Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Premetrexed (Alimta)

• Carboplatin

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response and Progression Free Survival		Up to five years after study completion	No

External Links

•   Kimmel Cancer Center at Thomas Jefferson University
•   Thomas Jefferson University Hospital