Whole-Brain Radiation Therapy and Pemetrexed in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer (NRR)
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.
|Lung Cancer Metastatic Cancer||Drug: pemetrexed disodium Radiation: radiation therapy||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Response of intracranial metastases (complete and partial response) [ Time Frame: 126 days ]Radiographic response will be measured by RECIST, indicating if subject experienced a Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)
- Number of subjects experiencing adverse events [ Time Frame: 126 days ]Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE)grading scale.
|Study Start Date:||May 2005|
|Study Completion Date:||April 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Single Arm Study
Single Arm Study
Drug: pemetrexed disodium
500 mg/m2 once every 21 days up to 126 daysRadiation: radiation therapy
Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy
- Estimate the response in patients with intracranial brain metastases from non-small cell lung cancer treated with whole-brain radiotherapy and pemetrexed disodium.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280748
|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|