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A Phase II Study of Treatment of Brain Metastases From Non-Small Cell Lung Cancer With Concurrent Whole Brain Radiation Therapy and Pemetrexed

Phase 2
18 Years
Not Enrolling
Lung Cancer, Metastatic Cancer

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Trial Information

A Phase II Study of Treatment of Brain Metastases From Non-Small Cell Lung Cancer With Concurrent Whole Brain Radiation Therapy and Pemetrexed



- 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

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

After completion of study treatment, patients are followed at 30 days and then every 2
months for 2 years.

Inclusion Criteria


- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Must have evidence of brain metastases by MRI or CT scan

- 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

- ANC > 1,500/mm³

- Platelet count > 100,000/mm³

- Hemoglobin ≥ 8 g/dL

- AST and ALT < 3 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- Creatinine clearance ≥ 45 mL/min

- No contraindication or intolerance to corticosteroid therapy

- No 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

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No HIV positivity

- No severe hypersensitivity to pemetrexed disodium

- Able to discontinue NSAIDs for ≥ 5 days

- No history of underlying dementia, Parkinson's disease, or Alzheimer's disease

- Able to take vitamins, folic acid, and corticosteroids


- 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 nonapproved or investigational drug

- No other concurrent chemotherapy, immunotherapy, hormonal therapy, radiotherapy,
surgery, or experimental medications

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response of intracranial metastases (complete and partial response)

Outcome Description:

Radiographic response will be measured by RECIST, indicating if subject experienced a Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)

Outcome Time Frame:

126 days

Safety Issue:


Principal Investigator

Thomas E. Stinchcombe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Federal Government

Study ID:

LCCC 0409



Start Date:

May 2005

Completion Date:

April 2009

Related Keywords:

  • Lung Cancer
  • Metastatic Cancer
  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • tumors metastatic to brain
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Alamance Oncology/Hematology Associates, LLP Burlington, North Carolina  27216