Drugs to Reduce the Side Effects of Chemotherapy

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific	Drug: dexamethasone; Drug: granisetron hydrochloride; Drug: metoclopramide hydrochloride	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	267 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Supportive Care
Official Title:	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
Study Start Date :	May 1996
Actual Primary Completion Date :	April 1999
Actual Study Completion Date :	August 1999

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Oral Granisetron + 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	Drug: dexamethasone; 4 mg Dexamethasone in the morning; Other Name: dexamethasone acetate Drug: granisetron hydrochloride; 1 mg Granisetron in the morning; Other Name: Kytril®
Experimental: Metoclopramide + Dexamethasone; 20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening) 4 mg Dexamethasone in the morning	Drug: dexamethasone; 4 mg Dexamethasone in the morning; Other Name: dexamethasone acetate Drug: metoclopramide hydrochloride; 20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening); Other Name: Metozolv®

Outcome Measures

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Primary Outcome Measures :

1. Complete and partial control of emesis [ Time Frame: Total control of emesis on every one of the 5 days following the acute phase ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

Italy
Istituto Europeo Di Oncologia
Milano, Italy, 20141
Switzerland
Kantonspital Aarau
Aarau, Switzerland, 5001
Office of Walter Weber-Stadelman
Basel, Switzerland, CH 4051
University Hospital
Basel, Switzerland, CH-4031
Inselspital, Bern
Bern, Switzerland, CH-3010
Hopital Cantonal Universitaire de Geneva
Geneva, Switzerland, CH-1211
Istituto Oncologico della Svizzera Italiana
Lugano, Switzerland, CH-6900
Burgerspital, Solothurn
Solothurn, Switzerland, 4500
City Hospital Triemli
Zurich, Switzerland, 8063
Klinik Hirslanden
Zurich, Switzerland, CH-8008

Sponsors and Collaborators

Swiss Group for Clinical Cancer Research

Investigators

Study Chair:	Matti S. Aapro, MD	European Institute of Oncology

More Information

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Publications of Results:

Aapro MS, Thuerlimann B, Sessa C, De Pree C, Bernhard J, Maibach R; Swiss Group for Clinical Cancer Research. A randomized double-blind trial to compare the clinical efficacy of granisetron with metoclopramide, both combined with dexamethasone in the prophylaxis of chemotherapy-induced delayed emesis. Ann Oncol. 2003 Feb;14(2):291-7.

Bernhard J, Maibach R, Thürlimann B, Sessa C, Aapro MS; Swiss Group for Clinical Cancer Research. Patients' estimation of overall treatment burden: why not ask the obvious? J Clin Oncol. 2002 Jan 1;20(1):65-72.

Aapro MS, Sessa C, Thurlimann B, et al.: SAKK 90/95: a randomized double-blind trial to compare the clinical efficacy of granisetron to metoclopramide, both combined to dexamethasone in the prophylaxis of chemotherapy induced delayed emesis. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A2360, 2000.

Responsible Party:	Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:	NCT00003213 History of Changes
Other Study ID Numbers:	SAKK 90/95; SWS-SAKK-90/95; EU-97035; CDR0000066073
First Posted:	August 2, 2004
Last Update Posted:	July 11, 2012
Last Verified:	July 2012

Keywords provided by Swiss Group for Clinical Cancer Research:

unspecified adult solid tumor, protocol specific; nausea and vomiting

Additional relevant MeSH terms:

Nausea; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Dexamethasone acetate; Dexamethasone; Metoclopramide; Granisetron; BB 1101; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents	Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Dopamine Agents; Neurotransmitter Agents; Serotonin Antagonists; Serotonin Agents