Lymphoma Clinical Trial
Official title:
Phase III, Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Ondansetron in the Control of Chronic Nausea and Vomiting Not Due to Antineoplastic Therapy in Patients With Advanced Cancer
RATIONALE: Antiemetic drugs, such as ondansetron, may help to reduce or prevent nausea and
vomiting in patients with advanced cancer.
PURPOSE: This randomized phase III trial is studying how well ondansetron works compared to
a placebo in treating patients with advanced cancer and chronic nausea and vomiting that is
not caused by cancer therapy.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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