Status:
WITHDRAWN
QOL-Stereotactic RadioSurgery, Temozolomide + Erlotinib-Rx of 1-3 Brain Metastases in NSCLC
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Schering-Plough
Conditions:
Lung Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Treatment with radiosurgery, temozolomide, and erlotinib may affect brain function (the ability to think, learn, remember, and judge) in patients with non-small cell lung cancer and brain m...
Detailed Description
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 metasta...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00385398
Start Date
July 1 2008
End Date
December 1 2008
Last Update
September 2 2013
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