Granisetron to Prevent Nausea and Vomiting After Chemotherapy in Patients With Malignant Disease
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|ClinicalTrials.gov Identifier: NCT00005024|
Recruitment Status : Unknown
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 23, 2004
Last Update Posted : January 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: granisetron hydrochloride||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Primary Purpose:||Supportive Care|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005024
|Study Chair:||Barbara J. Gitlitz, MD||Jonsson Comprehensive Cancer Center|