novottf-100l in combination with pemetrexed (alimta®) for advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer; NSCLC

Summary: an open-label phase i-ii trial will be performed in 42 patients with pretreated locally advanced non-small cell lung cancer. the trial is designed to estimate the efficacy and to determine safety of novottf-100l treatment combined with pemetrexed for advanced nsclc patients. patients will receive standard pemetrexed therapy (at 500 mg/m2 iv q3w for 3 cycles) concomitant to novottf-100l therapy (12 hours a day, daily until the end of all three cycles of alimta). repeat treatments with alimta + novottf-100l will be offered as long as the patient is stable or responding. if there is a in-field response with progression outside of the novottf field, pemetrexed is to be stopped and third line chemotherapy with docetaxel is to be initiated (35 mg/m2 weekly, d1, 8, 15, q 28 d).

the trial will be conducted in two stages. fourteen patients will be recruited to a phase i stage of the trial. after all 14 patients have received 3 courses of alimta (9 weeks of novottf-100l treatment), these patients will be analyzed for toxicity. if the incidence of device related serious adverse events is \< 20%, the trial will continue to the second stage where 42 patients will be assessed for safety and efficacy as part of a phase ii study (including the first 14 patients in the phase i study). efficacy will be assessed based on local disease control in the lungs and liver, time to systemic disease progression, and overall survival. patients will be followed for at least 6 months after the last course of novottf-100l is applied to assess survival.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-small cell lung cancer (nsclc) * stage iv or iiib with malignant pleural effusion, also locally advanced nsclc not otherwise amenable to local treatment (surgery or radiotherapy) * one line of prior chemotherapy * measurable disease * greater or equal to 18 years * life expectancy of at least 12 weeks * ecog performance status 0-2 * laboratory requirements at entry: * blood cell counts: * absolute neutrophils ≥ 1.0 x 109/l * platelets ≥100 x 109/l * hemoglobin ≥ 10 g/dl * renal function: * creatinine clearance ≥ 45 ml/min * hepatic functions: * asat and alat ≤ 3 x unl * alkaline phosphatase ≤ 5 x unl * signed informed consent prior to start protocol specific requirements * pregnancy test (β-hcg) must be negative (needed only for women of childbearing potential). exclusion criteria: * known brain metastases or meningeal carcinomatosis * other serious concomitant illness of medical conditions: * congestive heart failure or angina pectoris except if it is medically controlled. * previous history of myocardial infarction within 1 year from study entry. * uncontrolled hypertension or arrhythmias * implanted pacemaker, defibrillator or deep brain stimulation device * history of significant neurologic or psychiatric disorders including dementia or seizures * active infection requiring iv antibiotics * active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy * concurrent treatment with other experimental drugs * participation in clinical trials with other experimental agents within 30 days of study entry * psychological, familial, sociological or geographical conditions which don't permit medical follow-up and compliance with the study protocol

Keywords: ttfields nsclc alimta pemetrexed