Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Drugs to Reduce the Side Effects of Chemotherapy

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Closed 18 and over SWS-SAKK-90/95 EU-97035, NCT00003213

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.

Entry 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

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

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

Expected Enrollment

This study will accrue 360 patients.

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.

Aapro MS, Thuerlimann B, Sessa C, et al.: 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 14 (2): 291-7, 2003.[PUBMED Abstract]

Bernhard J, Maibach R, Thürlimann B, et al.: Patients' estimation of overall treatment burden: why not ask the obvious? J Clin Oncol 20 (1): 65-72, 2002.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Swiss Group for Clinical Cancer Research

Matti Aapro, MD, Protocol chair(Contact information may not be current)		Ph: 39-02-5748-9861

Registry Information
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
Trial Start Date		1996-05-28
Registered in ClinicalTrials.gov		NCT00003213
Date Submitted to PDQ		1998-02-10
Information Last Verified		2007-05-14