Phase II Study of Stereotactic Radiosurgery, Temozolomide and Erlotinib Chemotherapy for the Treatment of 1-3 Brain Metastases in Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer, Metastatic Cancer
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
OBJECTIVES:
Primary
- Determine the effect of stereotactic radiosurgery, temozolomide, and erlotinib
hydrochloride on cognitive function in patients with non-small cell lung cancer and
brain metastases.
Secondary
- 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
methylation.
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
DISEASE CHARACTERISTICS:
- 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
evaluation
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- 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:
Interventional
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:
No
Principal Investigator
Molly Gabel, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Institute of New Jersey
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000539474
NCT ID:
NCT00385398
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
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