Olanzapine for the Treatment of Chronic Nausea and/or Vomiting Unrelated to Chemotherapy or Radiation in Advanced Cancer Patient - A Pilot Dose-Finding Trial
Costantine Albany, MD
Primary Investigator
Overview
Description
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Cancer,Chronic nausea,advanced cancer
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion Criteria
Have histologically or cytologically-confirmed malignant disease in an advanced incurable stage
Have not received chemotherapy or radiation for >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)
Have chronic nausea that has been present for at least one week (worst daily score >3, 0-10 visual analogue scale) or vomiting at least five times over past one week
Women of childbearing potential must consent to use adequate contraception throughout protocol therapy; females of childbearing potential must have a negative urine pregnancy test 7 days prior to registration.
Exclusion Criteria
Not be receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for less than or equal to 30 days prior to registration or planned during protocol therapy (patients may have received prochloperazine and other phenothiazines as prior anti-emetic therapy)
Not have concurrent use of ethyol
Not have severe cognitive compromise
History of CNS disease (e.g. brain metastases, seizure disorder)
Concurrent use of amifostine, concurrent abdominal radiotherapy; concurrent use of quinolone antibiotic therapy
Known hypersensitivity to olanzapine
Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months
History of uncontrolled diabetes mellitus (stable insulin dose and/or stable oral hypoglycemic agent permitted)
Planned chemotherapy or radiation during the 7 days following study initiation.