Whole-Brain Radiation Therapy and Pemetrexed in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer (NRR)

UNC Lineberger Comprehensive Cancer Center

Status and phase

Terminated

Phase 2

Conditions

Metastatic Cancer

Lung Cancer

Treatments

Radiation: radiation therapy

Drug: pemetrexed disodium

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00280748

CDR0000551069 (Other Identifier)

LCCC 0409

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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