Phase II trial of a single intravenous dose of ondansetron in patients receiving cisplatin ≥ 100 mg/m(2) Journal Article


Authors: Kris, M. G.; Clark, R. A.; Tyson, L. B.; Hahne, W. F.; Pisters, K. M. W.; Gralla, R. J.
Article Title: Phase II trial of a single intravenous dose of ondansetron in patients receiving cisplatin ≥ 100 mg/m(2)
Abstract: Ondansetron, a serotonin antagonist antiemetic, controls emesis caused by cisplatin when given as multiple 0.15 mg/ kg dosages in a variety of administration schedules. This trial evaluated a single 0.45 mg/kg i.v. dose of ondansetron in 21 cancer patients receiving cisplatin at doses ≥ 100 mg/m2 as initial chemotherapy. Twenty-five percent of patients had no emetic episodes (95% confidence interval: 9-49%), and 45% had two or fewer emetic episodes (95% confidence interval: 23-69%). No significant adverse effects were seen. In prior trials at this institution in similarly treated patients, ondansetron given in three divided doses yielded a 42% no emesis rate. In this trial a single i.v. 0.45 mg/kg dose of ondansetron prevented emesis in 25% of patients receiving initial cisplatin ≥ 100 mg/m2. For this dose of cisplatin and ondansetron, the observed emesis complete control rate was lower than that previously seen using multiple dose schedules.
Keywords: adult; cancer chemotherapy; clinical article; aged; cisplatin; diarrhea; drug efficacy; cancer patient; phase 2 clinical trial; etoposide; vomiting; sedation; vinblastine; serotonin antagonist; ondansetron; antiemetic agent; headache; mitomycin; intravenous drug administration; cancer; human; male; female; article
Journal Title: American Journal of Clinical Oncology
Volume: 16
Issue: 1
ISSN: 0277-3732
Publisher: Lippincott Williams & Wilkins  
Date Published: 1993-02-01
Start Page: 77
End Page: 80
Language: English
DOI: 10.1097/00000421-199302000-00019
PUBMED: 8424410
PROVIDER: scopus
DOI/URL:
Notes: Source: Scopus
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MSK Authors
  1. Mark Kris
    869 Kris
  2. Leslie Tyson
    70 Tyson
  3. Katherine M. W. Pisters
    27 Pisters
  4. Richard J. Gralla
    69 Gralla
  5. Rebecca Clark
    21 Clark