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Spots Global Cancer Trial Database for Whole-Brain Radiation Therapy and Pemetrexed in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer

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Trial Identification

Brief Title: Whole-Brain Radiation Therapy and Pemetrexed in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer

Official Title: A Phase II Study of Treatment of Brain Metastases From Non-Small Cell Lung Cancer With Concurrent Whole Brain Radiation Therapy and Pemetrexed

Study ID: NCT00280748

Study Description

Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving whole-brain radiation therapy together with pemetrexed works in treating patients with brain metastases from non-small cell lung cancer.

Detailed Description: OBJECTIVES: Primary * Estimate the response in patients with intracranial brain metastases from non-small cell lung cancer treated with whole-brain radiotherapy and pemetrexed disodium. Secondary * Determine the toxicity of this regimen in these patients. * Estimate the overall survival of patients treated with this regimen. * Evaluate the functional status of patients treated with this regimen. * Assess neurological function and progression in patients treated with this regimen. * Determine the response of patients with extracranial disease treated with pemetrexed disodium. OUTLINE: Patients undergo whole-brain radiotherapy 5 days a week for 3 weeks beginning on day 1. Patients also receive pemetrexed disodium IV on day 1, 2, or 3 and day 28 of course 1, and on day 1 of each subsequent course. Treatment with pemetrexed disodium repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days and then every 2 months for 2 years.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Alamance Oncology/Hematology Associates, LLP, Burlington, North Carolina, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States

Contact Details

Name: Thomas E. Stinchcombe, MD

Affiliation: UNC Lineberger Comprehensive Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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