Abstract | PURPOSE: To determine the efficacy and safety of the neurokinin type 1 receptor antagonist CJ-11,974 for the control of high-dose cisplatin-induced emesis. PATIENTS AND METHODS: A double-blind, randomized, phase II design with a group sequential stopping rule was used in this study. Sixty-one patients with cancer who were receiving cisplatin at a dose of at least 100 mg/m2 for the first time were enrolled. All patients received granisetron 10 microg/kg and dexamethasone 20 mg intravenously 30 minutes before they were given cisplatin. Patients were randomly assigned to two groups: group 1 received CJ-11,974 100 mg, and group 2 received placebo orally 30 minutes before and 12 hours after cisplatin and then twice daily on days 2 through 5 after cisplatin. The primary end point was the percentage of patients who developed delayed emesis ( emesis on the second to fifth days after cisplatin). RESULTS: Thirty patients were enrolled in group 1, and 31 patients were enrolled in group 2. Fifty-eight patients were assessable for efficacy. Complete control of emesis (expressed as the percentage of patients who had no emesis) was as follows: day 1, 85.7% (group 1) and 66.7% (group 2) (P = .090); days 2 through 5, 67.8% (group 1) and 36.6% (group 2) (P = .0425, adjusted); days 1 through 5, 64.3% (group 1) and 30% (group 2) (P = .009). Patients in group 1 experienced significantly less nausea than patients in group 2 on day 1 (P = .024). Treatment was well tolerated in both groups. CONCLUSION:
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Authors | P J Hesketh, R J Gralla, R T Webb, W Ueno, S DelPrete, M E Bachinsky, N L Dirlam, C B Stack, S L Silberman |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 17
Issue 1
Pg. 338-43
(Jan 1999)
ISSN: 0732-183X [Print] United States |
PMID | 10458252
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antiemetics
- Antineoplastic Agents
- Benzene Derivatives
- CJ 11974
- Neurokinin-1 Receptor Antagonists
- Dexamethasone
- Cisplatin
- Granisetron
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Topics |
- Adult
- Aged
- Antiemetics
(adverse effects, therapeutic use)
- Antineoplastic Agents
(adverse effects)
- Benzene Derivatives
(adverse effects, therapeutic use)
- Cisplatin
(adverse effects)
- Dexamethasone
(therapeutic use)
- Double-Blind Method
- Female
- Granisetron
(therapeutic use)
- Humans
- Male
- Middle Aged
- Neurokinin-1 Receptor Antagonists
- Vomiting
(chemically induced, drug therapy, prevention & control)
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