Aprepitant for Germ Cell Chemotherapy: A phase II multi-centre trial of a seven day Aprepitant schedule for the prevention of chemotherapy induced nausea and vomiting in patients receiving five day cisplatin-based chemotherapy for germ cell tumours.

Exclusion Criteria11

• Patient has vomited in the 24 hours prior to Treatment Day 1.
• Previous chemotherapy.
• Patient has a symptomatic metastatic CNS malignancy.
• Patient has recieved radiation therapy to the abdomen or pelvis in the week prior to treatment, or will recieve radiation therapy to the abdomen or pelvis during days one to eight of treatment.
• Patient has an active infection (e.g. pneumonia) or any uncontrolled disease except for malignancy (e.g diabetic ketoacidosis, gastrointestinal obstruction) which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
• Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
• Patient has current evidence of alcohol abuse as determined by the investigator.
• Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
• Patient has a history of hypersensitivity to Aprepitant, Ondansetron, or Dexamethasone.
• Patient has previously participated in a study with Aprepitant.
• Patient has taken any of the following CYP3A4 substrates during the 7 days of treatment day 1: Terfenadine, Cisapride, Astemizole, or Pimozide.