Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Randomized, Double-Blind Trial to Compare the Clinical Efficacy and Safety of Granisetron vs. Metoclopramide Combined to Dexamethasone in the Prophylaxis of Chemotherapy-Induced Delayed Emesis
RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients
treated with chemotherapy. It is not known whether receiving dexamethasone with granisetron
is more effective than receiving dexamethasone with metoclopramide for reducing the side
effects of chemotherapy.
PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with
either granisetron or metoclopramide in patients treated with chemotherapy.
OBJECTIVES: I. Compare the clinical efficacy and safety of Granisetron or Metoclopramide in
combination with Dexamethasone in the prophylaxis of delayed nausea and vomiting induced by
emetogenic cancer chemotherapy in patients with or without emesis in the acute phase.
OUTLINE: This is a randomized, double blind study. Patients are stratified by prior
chemotherapy (yes vs no), regular alcohol consumption (yes vs no), and prior chemotherapy
regimen (cisplatin/carboplatin vs others). Patients receive dexamethasone and granisetron by
mouth bid on day 0. Patients are then randomized to receive either granisetron or
metoclopramide with dexamethasone concurrently with chemotherapy. Arm I: Patients receive
granisetron by mouth bid on days 1-5. Dexamethasone and a placebo are administered by mouth
once daily on days 1-5. Arm II: Patients receive metoclopramide by mouth tid on days 1-5.
Dexamethasone is administered by mouth once daily on days 1-5. Patients must complete a
diary card daily for 6 days.
PROJECTED ACCRUAL: This study will accrue 360 patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care
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