Whole-Brain Radiation Therapy and Pemetrexed in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer (NRR)
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|ClinicalTrials.gov Identifier: NCT00280748|
Recruitment Status : Terminated (Slow accrual)
First Posted : January 23, 2006
Results First Posted : June 23, 2017
Last Update Posted : June 23, 2017
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 or disease||Intervention/treatment||Phase|
|Lung Cancer Metastatic Cancer||Drug: pemetrexed disodium Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||April 2009|
Single Arm Study
Single Arm Study
Drug: pemetrexed disodium
500 mg/m2 once every 21 days up to 126 days
Other Name: Alimta
Radiation: 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
- Response of Intracranial Metastases (Complete and Partial Response) [ Time Frame: 126 days ]Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Number of Subjects Experiencing Adverse Events [ Time Frame: maximum 5 months ]Toxicities was assessed using Common Terminology Criteria for Adverse Events (CTCAE) grading scale. Only toxicities with attribution to chemotherapy of "definite" or "probable" are considered, as determined by treating physician.
- Estimate the Overall Survival of Patients Treated With This Regimen. [ Time Frame: 4 years ]Patients were followed for survival from start of treatment until death from any cause (up to 4 years)
- Evaluate the Functional Status of Patients Treated With This Regimen. [ Time Frame: baseline functional status only ]Functional status evaluated using the Karnofsky functional status scale. The Karnofsky Performance Scale (KPS) Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death.
- Neurological Function by Radiation Oncology Group (RTOG) Neurological Function Classification [ Time Frame: At Baseline, 30 days, and at end of treatment (maximum 5 months). ]
A classification score defined as follows:
- Able to work or to perform normal activities: neurological findings minor or absent
- Able to carry out normal activities with minimal difficulties. Neurological impairment does not require nursing care or hospitalization
- Seriously limited in performing normal activities. Requiring nursing care or hospitalization. Patients confined to bed or wheelchair or have significant intellectual impairment
- Unable to perform even minimal normal activities. Requiring hospitalization and constant nursing care and feeding. Patients unable to communicate or in coma.A higher score indicates worse function.
- Neurological Function by Mini Mental State Examination [ Time Frame: Baseline (pre-treatment), 30 days (Cycle 2 Day 1), and maximum 5 months (end of treatment). ]The Mini Mental State Examination is a 30-point questionnaire that is used to measure cognitive impairment. Score totals range from normal cognition (24-30 points), mild impairment (19-23 points), moderate impairment (10-18 points), to severe impairment (≤9 points).
- Response of Patients With Extracranial Disease Treated With Pemetrexed [ Time Frame: maximum 5 months ]Response was measured by Response Evaluation Criteria In Solid Tumors RECIST criteria v1.0. Complete Response (CR) - Disappearance of all lesions Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD) - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing nontarget lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|