Drugs to Reduce the Side Effects of Chemotherapy - Full Text View

Purpose

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	Intervention	Phase
Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific	Drug: dexamethasone Drug: granisetron hydrochloride Drug: metoclopramide hydrochloride	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Dexamethasone Metoclopramide Dexamethasone sodium phosphate Metoclopramide hydrochloride Dexamethasone acetate Granisetron hydrochloride Granisetron

U.S. FDA Resources

Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:

Complete and partial control of emesis [ Time Frame: Total control of emesis on every one of the 5 days following the acute phase ] [ Designated as safety issue: No ]


Enrollment:	267
Study Start Date:	May 1996
Study Completion Date:	August 1999
Primary Completion Date:	April 1999 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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®

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003213

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

Publications:

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
Study First Received:	November 1, 1999
Last Updated:	July 10, 2012
Health Authority:	Switzerland: Ethikkommission

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 Granisetron Metoclopramide Dexamethasone 21-phosphate 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 Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Dopamine D2 Receptor Antagonists Dopamine Antagonists Dopamine Agents

ClinicalTrials.gov processed this record on September 30, 2016