CIRABCilengitide (EMD121974) in Combination With Whole Brain Radiotherapy in Patients With Brain Metastases From Lung Cancer - a Single-center, Open-label Phase I Study

Date de début de l'étude : 1 décembre 2008

Inclusion Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed lung cancer (small cell or non-small cell lung cancer) * Patient must be eligible for whole-brain radiotherapy * Presence of brain metastasis (single or multiple, synchronous or metachronous) from lung cancer not amenable to surgery or radiosurgery (presence of metastases at any other site is allowed) * No leptomeningeal metastasis or known subarachnoid spread of tumor PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 (ECOG PS 2 allowed if due to the presence of cerebral metastases and not due to a high peripheral-tumor load or other reasons) * Life expectancy ≥ 3 months * Adequate hematologic function * Total bilirubin \< 1.5 times upper limit of normal (ULN) * AST, ALT, and alkaline phosphatase \< 2.5 times ULN * Creatinine clearance \> 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * No history of acute or chronic renal disease * No other malignancies treated within the past 5 years, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin * No uncontrolled hypertension * No history of coagulation disorder associated with bleeding or recurrent thrombotic events * No peptic ulcer disease within the past 6 months * No congestive heart failure, high risk for uncontrolled arrhythmia, or history of clinically significant coronary heart disease * No known alcohol or drug abuse * No other significant or acute concomitant disease * No dementia or altered mental status PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Concurrent corticosteroids allowed if the dosing regimen has ben stable ≥ 5 days * Concurrent anticonvulsants allowed if the dosing regimen has been stable for the past week * More than 30 days since prior participation in another clinical trial * No concurrent anticoagulation with vitamin K antagonists, therapeutic-dose anticoagulation with heparin resulting in prolonged PTT, or therapeutic-dose anticoagulation with low molecular weight heparin (low-dose \[i.e. prophylactic\], low molecular weight heparins allowed) * No prior whole-brain radiation or radiosurgery * No prior antiangiogenic therapy * No other concurrent anticancer therapy