Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial
Official title:
Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patients - A Confirmatory Phase III MNCCTN Trial
This phase III trial compares olanzapine to placebo in decreasing nausea and vomiting in patients with cancer that has spread to other places in the body (advanced). Patients with advanced cancer may experience nausea and/or vomiting that is unrelated to chemotherapy or radiation. Giving olanzapine may help reduce nausea and increase appetite in patients who have advanced cancer.
PRIMARY OBJECTIVE: I. To conduct a confirmatory phase III double-blind randomized clinical trial to evaluate the ability of olanzapine to decrease nausea in patients with advanced-cancer associated nausea/vomiting. SECONDARY OBJECTIVES: I. To evaluate toxicity associated with olanzapine in patients with advanced-cancer associated nausea/vomiting. II. To evaluate the effect of olanzapine on appetite, vomiting, sedation, sleep, the use of other antiemetic agents, fatigue, and well-being. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive olanzapine orally (PO) every night on days 1-28. ARM II: Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28. ;
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