Overview

Drugs to Reduce the Side Effects of Chemotherapy

Status:
Completed
Trial end date:
1999-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Swiss Group for Clinical Cancer Research
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Granisetron
Metoclopramide
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