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Phase II Study of Stereotactic Radiosurgery, Temozolomide and Erlotinib Chemotherapy for the Treatment of 1-3 Brain Metastases in Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer, Metastatic Cancer

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Trial Information

Phase II Study of Stereotactic Radiosurgery, Temozolomide and Erlotinib Chemotherapy for the Treatment of 1-3 Brain Metastases in Non-Small Cell Lung Cancer



- Determine the effect of stereotactic radiosurgery, temozolomide, and erlotinib
hydrochloride on cognitive function in patients with non-small cell lung cancer and
brain metastases.


- Determine the feasibility and safety of this regimen, in terms of tumor response, time
to tumor progression in brain, survival, physical functioning, and quality of life, in
these patients.

- Determine the frequency of O6-methylguanine-DNA methyltransferase promoter methylation
in these patients.

OUTLINE: This is a multicenter study.

Patients undergo stereotactic radiosurgery on day -7. Patients receive oral temozolomide
once daily on days 1-5 and oral erlotinib hydrochloride once daily on days 1-23. Treatment
with temozolomide and erlotinib hydrochloride repeats every 28 days in the absence of
disease progression or unacceptable toxicity.

Patients undergo cognitive function evaluation as measured by Mini-Mental Status Exam
administration and scoring; quality of life assessment as measured by Functional Assessment
of Cancer Therapy subscale; and physical functioning assessment as measured by Katz index of
activities of daily living and Karnofsky performance status at baseline and then every 8
weeks during study treatment.

Tumor tissue is examined by O6-methylguanine-DNA methyltransferase (MGMT gene) promotor

After completion of study therapy, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed non-small cell lung cancer meeting the following criteria:

- One to 3 brain metastases, meeting the following criteria:

- No larger than 3 cm

- Greater than 5 mm from the optic apparatus

- Not involving the brainstem, pons, medulla, or midbrain

- Stable systemic disease for the past 3 months

- Less than 3 months since completion of primary treatment

- Measurable CNS disease as defined by RECIST criteria

- No leptomeningeal disease documented by MRI or cerebrospinal fluid cytologic


- Life expectancy ≥ 12 weeks

- Karnofsky performance status 60-100%

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST ≤ 3.0 times ULN

- Serum creatinine ≤ 1.5 mg/dL

- Creatinine clearance > 50 mL/min

- No other malignancy within the past 5 years, except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No concurrent major medical illness or psychiatric impairment that, in the
investigator's opinion, would preclude study participation

- No concurrent active infections

- No known HIV positivity

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective nonhormonal contraception during and for 3 months
after completion of study treatment


- See Disease Characteristics

- No prior complete resection of all brain metastases

- No prior brain radiation therapy

- No prior temozolomide or erlotinib hydrochloride

- No concurrent enzyme-inducing anti-epileptic drugs

- No concurrent recombinant interleukin-11

- No other concurrent anticancer investigational or commercial agents or therapies,
including chemotherapy, immunotherapy, hormonal cancer therapy, radiation therapy, or
cancer surgery

- No concurrent enrollment on another clinical trial

- Surgery for symptomatic brain lesions prior to radiosurgery allowed

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cognitive function

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Molly Gabel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

December 2008

Related Keywords:

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