Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment

OBJECTIVES: I. Compare the antiemetic effect of ondansetron vs placebo in patients with
advanced cancer who suffer from chronic nausea and emesis that is not due to antineoplastic
therapy (i.e., chemotherapy, radiotherapy, immunotherapy, biologic therapy). II. Determine
the toxicity of ondansetron in these patients. III. Evaluate the use of other concurrent
antiemetics in these patients when treated with this regimen.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are stratified according to abdominal carcinomatosis (yes vs no), renal insufficiency
(creatinine less than 2.0 mg/dL vs creatinine at least 2.0 mg/dL), type of cancer (brain vs
gastrointestinal vs other), and narcotic use (yes vs no). Patients are randomized to one of
two treatment arms. Arm I: Patients receive oral ondansetron twice daily on days 1-7 and
oral placebo twice daily on days 8-14 in the absence of unacceptable toxicity. Arm II:
Patients receive oral placebo twice daily on days 1-7 and oral ondansetron twice daily on
days 8-14 in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study
within 1 year.

DISEASE CHARACTERISTICS: Diagnosis of incurable cancer with chronic nausea and vomiting
lasting at least 1 week that is not due to antineoplastic therapy (i.e., chemotherapy,
radiotherapy, immunotherapy, biologic therapy) Nausea not adequately controlled by
standard antiemetics

PATIENT CHARACTERISTICS: Cardiovascular: No uncontrolled hypertension Other: Not pregnant
or nursing Able to take oral medication (feeding tube allowed) Able to swallow own saliva
No prior phenylketonuria No known allergy or intolerance to 5-HT3 receptor antagonists No
bowel obstruction

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics At least 2 weeks since prior cytotoxic systemic therapy No
concurrent cytotoxic systemic therapy Endocrine therapy: Not specified Radiotherapy: See
Disease Characteristics At least 2 weeks since prior radiotherapy to gastrointestinal
tract No concurrent radiotherapy to gastrointestinal tract Surgery: Not specified Other:
At least 2 weeks since prior 5-HT3 receptor antagonists (i.e., dolasetron, granisetron, or
ondansetron) No other concurrent 5-HT3 receptor antagonists Other concurrent antiemetics
allowed