Whole-Brain Radiation Therapy and Pemetrexed in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer
Condition: Lung Cancer; Metastatic Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Brain Neoplasms
Intervention: pemetrexed disodium; radiation therapy
Intervention description: 500 mg/m2 once every 21 days up to 126 days; 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
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent non-small cell lung cancer; stage IV non-small cell lung cancer; tumors metastatic to brain

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.
    

Eligibility criteria:

        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

        Inclusion Criteria:

          -  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 Criteria:

          -  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