TY - JOUR
T1 - Phase II trials of the serotonin antagonist GR38032F for the control of vomiting caused by cisplatin
AU - Kris, Mark G.
AU - Gralla, Richard J.
AU - Clark, Rebecca A.
AU - Tyson, Leslie B.
N1 - Funding Information:
Received August 30, 1988; revised October 11, 1988; accepted October 12, 1988. Supported in part by Public Health Service grant CA-05826 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, and Glaxo, Inc. Dr. Kris is a recipient of the American Cancer Society Clinical Oncology Career Development Award. Solid Tumor Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center and Cornell University Medical College, New York, NY. We thank Dr. James Chubb, Dr. Andrew Finn, and Ms. Karen Werner for their support in the planning and conduct of these trials. * Correspondence to: Mark G. Kris, M.D., Solid Tumor Service, Memorial Sloan-Kettering Cancer Center, 1275 York Ave., New York, NY 10021.
PY - 1989/1
Y1 - 1989/1
N2 - 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].
AB - 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].
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U2 - 10.1093/jnci/81.1.42
DO - 10.1093/jnci/81.1.42
M3 - Article
C2 - 2521184
AN - SCOPUS:0024496307
VL - 81
SP - 42
EP - 46
JO - Journal of the National Cancer Institute
JF - Journal of the National Cancer Institute
SN - 0027-8874
IS - 1
ER -