NCT00005024

Granisetron to Prevent Nausea and Vomiting After Chemotherapy in Patients With Malignant Disease

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	cyclophosphamide
DRUG	doxorubicin hydrochloride
DRUG	granisetron hydrochloride

Timeline

• First posted: 2004-08-23
• Last updated: 2014-01-06