Status:
TERMINATED
Whole-Brain Radiation Therapy and Pemetrexed in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Must have evidence of brain metastases by MRI or CT scan
- PRIOR CONCURRENT THERAPY:
- Recovered from prior oncologic or major surgery
- Prior resection of all brain metastases or only site of brain metastases allowed provided there is radiologically evaluable intracranial metastases
- No prior cranial irradiation, including stereotactic radiosurgery
- More than 30 days since prior non-approved or investigational drug
- No other concurrent chemotherapy, immunotherapy, hormonal therapy, radiotherapy, surgery, or experimental medications
- No single brain metastases or oligometastatic disease amenable to surgical resection or radiosurgery
- Relapsed NSCLC with brain metastases allowed
- Not a candidate for double-agent or platinum-based chemotherapy
- No leptomeningeal metastases
- No clinically relevant (defined by physical exam) pleural effusions or ascites that cannot be controlled with drainage or other procedures
- Karnofsky performance status 70-100% OR ≥ 70 years of age
- Life expectancy \> 3 months
- Absolute neutrophil count (ANC) \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Hemoglobin ≥ 8 g/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Creatinine clearance ≥ 45 mL/min
- Able to take vitamins, folic acid, and corticosteroids
Exclusion
- Contraindication or intolerance to corticosteroid therapy
- Other malignancies within the past 5 years and disease-free OR prognosis is best defined by the NSCLC in the opinion of the attending physician
- Pregnant or nursing
- Positive pregnancy test
- Fertile patients must use effective contraception
- HIV positive
- Severe hypersensitivity to pemetrexed disodium
- Unable to discontinue NSAIDs for ≥ 5 days
- History of underlying dementia, Parkinson's disease, or Alzheimer's disease
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00280748
Start Date
May 1 2005
End Date
April 1 2009
Last Update
June 23 2017
Active Locations (2)
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1
Alamance Oncology/Hematology Associates, LLP
Burlington, North Carolina, United States, 27216
2
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295