Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Double-blind, Multicenter, Parallel Study Comparing the Efficacy and Safety of Kytril Tablets With Placebo, in the Prevention of Nausea and Vomiting During the Days Following Administration of IV Cyclophosphamide-based or Carboplatin-based Chemotherapy in Patients With Malignant Disease
RATIONALE: Antiemetic drugs such as granisetron may help to prevent nausea and vomiting in
patients treated with chemotherapy.
PURPOSE: Randomized phase III trial to compare the effectiveness of granisetron with that of
a placebo in preventing nausea and vomiting after chemotherapy in patients who have
malignant disease.
OBJECTIVES: I. Compare the efficacy and safety of oral granisetron versus placebo in
preventing nausea and vomiting during the 48 hours that begins 24 hours after administration
of cyclophosphamide-based or carboplatin-based chemotherapy regimens in patients with
malignant disease.
OUTLINE: This is a randomized, double blind, placebo controlled, parallel, multicenter
study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral
granisetron on day 0 at 60 minutes prior to the scheduled administration of IV
cyclophosphamide or carboplatin (or doxorubicin) chemotherapy. On days 1 and 2, patients
receive oral granisetron at approximately the same time as on day 0. Arm II: Patients
receive oral granisetron on day 0 as in arm I. On days 1 and 2, patients receive oral
placebo at approximately the same time as the granisetron tablets were taken on day 0.
Patients are followed between 5 and 11 days after the last dose of study medication.
PROJECTED ACCRUAL: A total of 434 patients (217 per arm) will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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