Patients who have previously completed or been withdrawn from this study or any other study with the respective medication in this study, have had treatment with an investigational new drug, currently or within the last 30 days, and/or participation in another clinical trial, currently or during the last 12 weeks, and/or previous participation in this study, history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study, with any clinically significant disease that in the opinion of the investigator is likely to put the patient at risk or to interfere with the evaluation of the patient's safety and of the study outcome (this includes, but is not limited to: clinically significant cardiac disease [e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication] or myocardial infarction within the last 6 months, uncontrolled hypertension, interstitial pneumonia or extensive or symptomatic interstitial fibrosis of the lung, pleural effusion or ascites, which cause respiratory compromise), a history or presence of any CNS disorder or psychiatric disability judged by the investigator to be clinically significant and/or interfering with compliance, a serious concomitant systemic disorder (e.g. active infection including HIV) that in the opinion of the investigator would compromise the patient's ability to complete the study, post-operative complications or other surgery-related conditions that could interfere with a study participation, hearing function/tinnitus impeding chemotherapy with Cisplatin
, alcohol and/or drug abuse, inability to interrupt high dose salicylates (like Aspirin
) or other non-steroidal anti-inflammatory drugs (NSAID's) for a 5-day period starting 2 days before administration of Pemetrexed
(8-day period for long-acting agents such as Piroxicam
) and patients with organ allografts, neurologic disorders and who cannot be regularly observed for psychological, sociological or geographical reasons or other concomitant conditions not permitting adequate follow-up and compliance to the protocol are not eligible.