Drugs to Reduce the Side Effects of Chemotherapy

Phase 3

Completed

• Conditions: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: dexamethasone; Drug: metoclopramide hydrochloride; Drug: granisetron hydrochloride

• Registration Number: NCT00003213
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1996-05
• Primary Completion: 1999-04
• Study Completion: 1999-08
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-07-30
• Study First Posted: 2004-08-02
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metoclopramide + Dexamethasone	metoclopramide hydrochloride	20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening) 4 mg Dexamethasone in the morning
Oral Granisetron + Dexamethasone	dexamethasone	1 mg Granisetron in the morning 1 Metoclopramide placebo in the afternoon 1 mg Granisetron in the evening 4 mg Dexamethasone in the morning
Oral Granisetron + Dexamethasone	granisetron hydrochloride	1 mg Granisetron in the morning 1 Metoclopramide placebo in the afternoon 1 mg Granisetron in the evening 4 mg Dexamethasone in the morning
Metoclopramide + Dexamethasone	dexamethasone	20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening) 4 mg Dexamethasone in the morning

Primary Outcome Measures

Name	Time	Method
Complete and partial control of emesis	Total control of emesis on every one of the 5 days following the acute phase

Trial Locations

Locations (10)

Istituto Oncologico della Svizzera Italiana; 🇨🇭 Lugano, Switzerland

Burgerspital, Solothurn; 🇨🇭 Solothurn, Switzerland

Istituto Europeo Di Oncologia; 🇮🇹 Milano, Italy

University Hospital; 🇨🇭 Basel, Switzerland

Kantonspital Aarau; 🇨🇭 Aarau, Switzerland

Office of Walter Weber-Stadelman; 🇨🇭 Basel, Switzerland

Inselspital, Bern; 🇨🇭 Bern, Switzerland

Hopital Cantonal Universitaire de Geneva; 🇨🇭 Geneva, Switzerland

City Hospital Triemli; 🇨🇭 Zurich, Switzerland

Klinik Hirslanden; 🇨🇭 Zurich, Switzerland