Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280748
Status:
TERMINATED
Last Update Posted:
2017-06-23
First Post:
2006-01-19
Brief Title:
Whole-Brain Radiation Therapy and Pemetrexed in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NRR
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000551069 | OTHER | PDQ number | None |