Randomized phase II study of the neurokinin 1 receptor antagonist CJ- 11,974 in the control of cisplatin-induced emesis

Paul J. Hesketh, R. J. Gralla, R. T. Webb, W. Ueno, S. DelPrete, M. E. Bachinsky, N. L. Dirlam, C. B. Stack, S. L. Silberman

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98 Scopus citations

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 μg/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: We conclude from this exploratory phase II trial that CJ-11,974 is superior to placebo in controlling cisplatin-induced delayed emesis and may provide additive benefit in acute emesis and nausea control when combined with a 5-hydroxytryptamine-3 receptor antagonist and dexamethasone. Additional larger trials are indicated to confirm the clinical value of CJ- 11,974.

Original languageEnglish (US)
Pages (from-to)338-343
Number of pages6
JournalJournal of Clinical Oncology
Volume17
Issue number1
StatePublished - Jan 1 1999

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Hesketh, P. J., Gralla, R. J., Webb, R. T., Ueno, W., DelPrete, S., Bachinsky, M. E., Dirlam, N. L., Stack, C. B., & Silberman, S. L. (1999). Randomized phase II study of the neurokinin 1 receptor antagonist CJ- 11,974 in the control of cisplatin-induced emesis. Journal of Clinical Oncology, 17(1), 338-343.