Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Patients with Advanced Cancer

Inclusion Criteria

• Age >= 18 years
• Histologically or cytologically-confirmed cancer in an advanced incurable stage
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Chronic nausea that has been present for at least one week (daily score > 5, on a 0-10 visual analogue scale)
• Serum creatinine < 2.0 mg/dl =< 120 days prior to registration
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) values < 3 times upper limits of normal =< 120 days prior to registration
• Negative pregnancy test done =< 14 days prior to registration, for persons of childbearing potential only
• Able to provide written informed consent
• Able to complete questionnaire(s) by themselves or with assistance

Exclusion Criteria

• Any of the following because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects: * Pregnant persons * Nursing persons
• Received chemotherapy or radiation within the prior 14 days (advanced cancer patients receiving hormonal therapy or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible)
• Receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for =< 30 days prior to registration or planned during protocol therapy (patients may have received prochloperazine and other phenothiazines as prior anti-emetic therapy)
• Those with concurrent use of ethyol; severe cognitive compromise; concurrent use of amifostine; concurrent use of quinolone antibiotic therapy; known hypersensitivity to olanzapine; or have planned chemotherapy or radiation during the 7 days following study initiation
• Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection (including human immunodeficiency virus [HIV]) * Cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient * Psychiatric illness/social situations that would limit compliance with study requirements
• Inability to swallow oral formulations of the agent(s)
• Tube feeding or nasogastric tube