A Phase II Study of Treatment of Brain Metastases From Non-Small Cell Lung Cancer With Concurrent Whole Brain Radiation Therapy and Pemetrexed
- 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
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
After completion of study treatment, patients are followed at 30 days and then every 2
months for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response of intracranial metastases (complete and partial response)
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)
Thomas E. Stinchcombe, MD
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Alamance Oncology/Hematology Associates, LLP||Burlington, North Carolina 27216|