Phase II trials of the serotonin antagonist GR38032F for the control of vomiting caused by cisplatin Journal Article
| Authors: | Kris, M. G.; Gralla, R. J.; Clark, R. A.; Tyson, L. B. |
| Article Title: | Phase II trials of the serotonin antagonist GR38032F for the control of vomiting caused by cisplatin |
| Abstract: | Three phase II studies of the serotonin antagonist GR38032F were conducted. In trial 1, 20 patients given initial chemotherapy with cisplatin at doses >=100 mg/m were randomized to receive three GR38032F doses (0.18 mg/kg) on an every-2-hour or every-4-hour schedule. In trial 2, eight similar patients were given three 0.04-mg/kg doses every 2 hours. In trial 3, 12 previously treated patients receiving cisplatin at 20-25 mg/m on 4 or 5 consecutive days each received three daily GR38032F doses (0.15 mg/kg) every 2 hours. In trial 1, 35% of the patients had no emesis (95%) confidence interval (CI), 16%-58%) and 55% had one or two emetic episodes (95% CI, 32%-76%). Results were similar between the every-2-hour and every-4-hour schedules. In trial 2, only one of eight patients (13%) had no vomiting (95% CI, 1%-50% ). In trial 3, in which previously treated patients were studied, complete control ranged from 75% on day 1 to 33% on day 3. Mild sedation, headache, and transient elevations of serum SGOT (AST) were observed. No extrapyramidal symptoms occurred. A dose of 0.15-0.18 mg/ kg every 2 hours for three iv doses is recommended. Further comparison and combination studies of GR38032F are warranted. [J Natl Cancer Inst 1989;81:42-46]. © 1989 Oxford University Press. |
| Keywords: | adult; clinical article; aged; cisplatin; phase 2 clinical trial; nausea; vomiting; ondansetron; headache; intravenous drug administration; imidazoles; middle age; drug evaluation; serotonin antagonists; human; male; female; priority journal; support, non-u.s. gov't; support, u.s. gov't, p.h.s. |
| Journal Title: | JNCI: Journal of the National Cancer Institute |
| Volume: | 81 |
| Issue: | 1 |
| ISSN: | 0027-8874 |
| Publisher: | Oxford University Press |
| Date Published: | 1989-01-04 |
| Start Page: | 42 |
| End Page: | 46 |
| Language: | English |
| DOI: | 10.1093/jnci/81.1.42 |
| PUBMED: | 2521184 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 14 April 2020 -- Source: Scopus |
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