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	Treatment or Intervention	Phase
solid tumor Nausea Vomiting	Drug: dexamethasone  Drug: granisetron  Drug: metoclopramide	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL 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

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

Study chairs or principal investigators

Matti S. Aapro,  Study Chair,  Swiss Institute for Applied Cancer Research   

Study ID Numbers:  CDR0000066073; SWS-SAKK-90/95; EU-97035
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003213
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08