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


Phase 1
18 Years
N/A
Not Enrolling
Both
Inoperable Non Small Cell Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response and Progression Free Survival

Principal Investigator

Maria Werner-Wasik, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University

Authority:

United States: Institutional Review Board

Study ID:

05C.276

NCT ID:

NCT00330044

Start Date:

April 2006

Completion Date:

October 2009

Related Keywords:

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

Name

Location
Thomas Jefferson University Hospital Philadelphia, Pennsylvania  19131