Granisetron to Prevent Nausea and Vomiting After Chemotherapy in Patients With Malignant Disease
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00005024
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method