Drugs to Reduce the Side Effects of Chemotherapy

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003213
• Other study ID #: SAKK 90/95
• Secondary ID: SWS-SAKK-90/95EU
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 10, 2012
• Start date: May 1996
• Est. completion date: August 1999

Study information

• Verified date: July 2012
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: August 1999
• Est. primary completion date: April 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nausea and Vomiting
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• dexamethasone
4 mg Dexamethasone in the morning
• granisetron hydrochloride
1 mg Granisetron in the morning
• metoclopramide hydrochloride
20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening)

Locations

Country	Name	City	State
Italy	Istituto Europeo Di Oncologia	Milano
Switzerland	Kantonspital Aarau	Aarau
Switzerland	Office of Walter Weber-Stadelman	Basel
Switzerland	University Hospital	Basel
Switzerland	Inselspital, Bern	Bern
Switzerland	Hopital Cantonal Universitaire de Geneva	Geneva
Switzerland	Istituto Oncologico della Svizzera Italiana	Lugano
Switzerland	Burgerspital, Solothurn	Solothurn
Switzerland	City Hospital Triemli	Zurich
Switzerland	Klinik Hirslanden	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Countries where clinical trial is conducted

Italy,  Switzerland, 

References & Publications (3)

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] Pr

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 prop — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete and partial control of emesis		Total control of emesis on every one of the 5 days following the acute phase	No