Drugs to Reduce the Side Effects of Chemotherapy

A Randomized, Double-Blind Trial to Compare the Clinical Efficacy and Safety of Granisetron vs. Metoclopramide Combined to Dexamethasone in the Prophylaxis of Chemotherapy-Induced Delayed Emesis

Sponsors

Lead Sponsor: Swiss Group for Clinical Cancer Research

Source 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.

Overall Status Completed
Start Date May 1996
Completion Date August 1999
Primary Completion Date April 1999
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Complete and partial control of emesis Total control of emesis on every one of the 5 days following the acute phase
Enrollment 267
Condition
Intervention

Intervention Type: Drug

Intervention Name: dexamethasone

Description: 4 mg Dexamethasone in the morning

Other Name: dexamethasone acetate

Intervention Type: Drug

Intervention Name: granisetron hydrochloride

Description: 1 mg Granisetron in the morning

Arm Group Label: Oral Granisetron + Dexamethasone

Other Name: Kytril®

Intervention Type: Drug

Intervention Name: metoclopramide hydrochloride

Description: 20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening)

Arm Group Label: Metoclopramide + Dexamethasone

Other Name: Metozolv®

Eligibility

Criteria:

DISEASE CHARACTERISTICS: Scheduled to receive a first course of highly emetogenic single day cancer chemotherapy regimens including: Cisplatin at least 50 mg/m2 Carboplatin at least 300 mg/m2 Dacarbazine at least 500 mg/m2 Doxorubicin at least 40 mg/m2 Epirubicin at least 60 mg/m2 Ifosfamide at least 1200 mg/m2 Cyclophosphamide at least 600 mg/m2

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Must be able to complete diary card (fluent in German, French, or Italian) No severe concurrent illness No other etiologies that cause vomiting, including: Gastrointestinal obstruction Hypercalcemia CNS metastases No active peptic ulceration No prior gastrointestinal bleeding due to peptic ulcer No moderate to severe nausea or any vomiting in the 24 hours prior to chemotherapy Not pregnant or lactating

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 months since prior chemotherapy Concurrent etoposide and fluorouracil allowed (days 1-5) No chemotherapy before day 0 of study Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent antiemetics No concurrent high dose benzodiazepines No concurrent psychotropic agents

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Matti S. Aapro, MD Study Chair European Institute of Oncology
Location
Facility:
Istituto Europeo Di Oncologia | Milano, 20141, Italy
Kantonspital Aarau | Aarau, 5001, Switzerland
Office of Walter Weber-Stadelman | Basel, CH 4051, Switzerland
University Hospital | Basel, CH-4031, Switzerland
Inselspital, Bern | Bern, CH-3010, Switzerland
Hopital Cantonal Universitaire de Geneva | Geneva, CH-1211, Switzerland
Istituto Oncologico della Svizzera Italiana | Lugano, CH-6900, Switzerland
Burgerspital, Solothurn | Solothurn, 4500, Switzerland
City Hospital Triemli | Zurich, 8063, Switzerland
Klinik Hirslanden | Zurich, CH-8008, Switzerland
Location Countries

Italy

Switzerland

Verification Date

July 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Oral Granisetron + Dexamethasone

Type: Experimental

Description: 1 mg Granisetron in the morning 1 Metoclopramide placebo in the afternoon 1 mg Granisetron in the evening 4 mg Dexamethasone in the morning

Label: Metoclopramide + Dexamethasone

Type: Experimental

Description: 20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening) 4 mg Dexamethasone in the morning

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: Double

Source: ClinicalTrials.gov