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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00280748 |
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.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Lung Cancer |
Drug: pemetrexed disodium Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | May 2005 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have evidence of brain metastases by MRI or CT scan
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |
Alamance Oncology/Hematology Associates, LLP | |
BURLINGTON, North Carolina, United States, 27216 | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7295 |
Principal Investigator: | Thomas E. Stinchcombe, MD | UNC Lineberger Comprehensive Cancer Center |
Study ID Numbers: | CDR0000551069, UNC-LCCC-0409 |
Study First Received: | January 19, 2006 |
Last Updated: | January 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00280748 |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage IV non-small cell lung cancer adult tumors metastatic to brain |
Thoracic Neoplasms Non-small cell lung cancer Central Nervous System Neoplasms Recurrence Carcinoma Folic Acid Pemetrexed |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis Carcinoma, Non-Small-Cell Lung Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Antimetabolites Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Enzyme Inhibitors |
Folic Acid Antagonists Pharmacologic Actions Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses |