Clinical trial NCT00096265 (phase 3, status: terminated)
Conditions: metastatic malignant neoplasm in the brain, recurrent non-small cell lung carcinoma, stage iv non-small cell lung cancer ajcc v7
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, D02.20, D02.21, D02.22, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: erlotinib hydrochloride, temozolomide
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, CSCC[C@H](N)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed non-small cell lung cancer

          -  One to 3 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the
             following criteria:

               -  Well circumscribed tumor(s)

               -  Maximum diameter ≤ 4.0 cm

                    -  If multiple lesions are present and one lesion is at the maximum diameter,
                       the other lesions must not exceed 3.0 cm in maximum diameter

               -  No metastases within 10 mm of the optic apparatus such that a portion of the
                  optic nerve or chiasm would be included in the high-dose stereotactic
                  radiosurgery boost field

               -  No metastases in the brainstem, midbrain, pons, or medulla

          -  No prior complete resection of all known brain metastases

               -  Subtotal resection allowed provided residual disease is ≤ 4.0 cm in maximum
                  diameter

          -  No clinical or radiographic evidence of progression (other than study lesion[s])
             within the past month

               -  Patients with brain metastases at initial presentation do not require 1 month of
                  scans documenting stable disease

          -  Stable extracranial metastases allowed

               -  No known or pre-existing liver metastases

          -  No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation

          -  Synchronous brain metastases at initial diagnosis allowed

          -  Performance status - Zubrod 0-1

          -  Hemoglobin ≥ 8 g/dL

          -  Absolute neutrophil count ≥ 1,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  AST < 2 times upper limit of normal (ULN)

          -  Alkaline phosphatase < 2 times ULN unless due to elevated bone metastases

          -  Total bilirubin normal

          -  Lactic dehydrogenase < 2 times ULN

          -  Creatinine < 1.5 times ULN

          -  No clinically active interstitial lung disease

               -  Chronic stable asymptomatic radiographic changes allowed

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  Neurologic function status 0-2

          -  No other major medical illness or psychiatric impairment that would preclude study
             participation

          -  No history of allergic reaction attributed to compounds of similar chemical or
             biologic composition to erlotinib or temozolomide

          -  No concurrent immunotherapy

          -  No concurrent biologic therapy, excluding growth factors and epoetin alfa

          -  No prior temozolomide or erlotinib

          -  No other concurrent chemotherapy during study radiotherapy

               -  Other concurrent chemotherapy allowed after study radiotherapy, except for the
                  following:

                    -  Temozolomide or erlotinib (arm I only)

                    -  Erlotinib (arm II only)

                    -  Temozolomide (arm III only)

          -  No prior cranial radiotherapy

          -  No concurrent intensity-modulated radiotherapy

          -  Concurrent radiotherapy to painful bone lesions allowed

               -  No concurrent radiotherapy to more than 15% of bone marrow

          -  No other concurrent therapy for brain metastases unless a recurrence is detected

          -  More than 30 days since prior investigational drugs

          -  No concurrent enzyme-inducing antiepileptic drugs including, but not limited to, any
             of the following (for patients randomized to receive erlotinib):

               -  Phenytoin

               -  Carbamazepine

               -  Rifampin

               -  Phenobarbital

               -  Primidone

               -  Oxcarbazepine

          -  No other concurrent investigational drugs

          -  No concurrent Hypericum perforatum (St. John's wort)

          -  No drugs that alter gastric pH (e.g., proton pump inhibitors or H2 antagonists) within
             4 hours after erlotinib administration (arm III patients only)