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
18 Years
N/A
Both
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Complete and partial control of emesis
Outcome Time Frame:
Total control of emesis on every one of the 5 days following the acute phase
Safety Issue:
No
Principal Investigator
Matti S. Aapro, MD
Investigator Role:
Study Chair
Investigator Affiliation:
European Institute of Oncology
Authority:
Switzerland: Ethikkommission
Study ID:
SAKK 90/95
NCT ID:
NCT00003213
Start Date:
May 1996
Completion Date:
August 1999
Related Keywords:
- Nausea and Vomiting
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- nausea and vomiting
- Nausea
- Vomiting
Name | Location |
|---|
