Stratified, randomized, double-blind comparison of intravenous ondansetron administered as a multiple-dose regimen versus two single-dose regimens in the prevention of cisplatin-induced nausea and vomiting

Journal of Clinical Oncology

Volumn 10, Issue 12, 1992, Pages 1969-1975

  Beck, Thomas M ^a   Hesketh, Paul J ^b   Madajewicz, Stefan ^b   Navari, Rudolph M ^b   Pendergrass, Kelly ^b   Lester, Eric P ^b   Kish, Julie A ^b   Murphy, William K ^b   Hainsworth, John D ^b   Gandara, David R ^b   Bricker, Leslie J ^b   Keller, Alan M ^b   Mortimer, Joanne ^b   Galvin, Daniel V ^b   House, Karen W ^b   Bryson, Judy C ^b  

^a St Luke's Mountain States Tumor Institute   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CISPLATIN; ONDANSETRON;

ADULT; ARTICLE; CANCER CHEMOTHERAPY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; ENZYME BLOOD LEVEL; FEMALE; HEADACHE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; NAUSEA; PRIORITY JOURNAL; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; CISPLATIN; COMPARATIVE STUDY; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMAN; INJECTIONS, INTRAVENOUS; MALE; MIDDLE AGE; NAUSEA; ONDANSETRON; SUPPORT, NON-U.S. GOV'T; VOMITING;

EID: 0027081530     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1992.10.12.1969     Document Type: Article

References (18)

1. Von Hoff D, Schilsky R, Reicher CM, et al: Toxic effects of cis-Dichlorodiammineplatinum (II) in man. Cancer Treat Rep 63:1527-1531, 1979
2. Gralla RJ, Itri LM, Pisko SE, et al: Antiemetic efficacy of high dose metoclopramide; randomized trials with placebo and prochlorperazine in patients with chemotherapy-induced nausea and vomiting. N Engl J Med 305:905-909, 1981
3. Cubeddu LX, Hoffmann IS, Fuenmayor NT, et al: Efficacy of ondansetron (GR38032F) and the role of serotonin in cisplatin-induced nausea and vomiting. N Engl J Med 322:810-816, 1990
4. 3 receptors and cytotoxic drug-induced vomiting. Trends Pharmacol Sci 8:44-45, 1987
5. 3-receptor antagonist, GR38032F. Cancer Treat Rev 14:333-336, 1987
6. Costall B, Domeney AM, Gunning SJ, et al: GR38032F: A potent and novel inhibitor of cisplatin-induced emesis in the ferret. Br J Pharmacol 90:90, 1987 (suppl; abstr)
7. Hainsworth J, Harvey W, Pendergrass K, et al: A single-blind comparison of intravenous ondansetron, a selective serotonin antagonist, with intravenous metoclopramide in the prevention of nausea and vomiting associated with high-dose cisplatin chemotherapy. J Clin Oncol 9:721-728, 1991
8. 3 (serotonin) antagonist ondansetron (GR38032F) with high-dose metoclopramide in the control of cisplatin-induced emesis. N Engl J Med 322:816-821, 1990
9. Lane M, Grunberg S, Lester EP, et al: A double-blind comparison of three dose levels of IV ondansetron (OND) in the prevention of cisplatin (DDP)-induced nausea and vomiting. Proc Am Soc Clin Oncol 9:329, 1990 (abstr)
10. Kris MG, Gralla RJ, Clark RA, et al: Phase II trials of the serotonin antagonist GR38032F for the control of vomiting caused by cisplatin. JNCI 81:42-46, 1989
11. Hesketh PJ, Murphy WK, Lester EP, et al: GR38032F (GR-C507/75): A novel compound effective in the prevention of acute cisplatin-induced emesis. J Clin Oncol 7:700-705, 1989
12. DeMulder PHM, Seynaeve C, Vermorken JB, et al: Ondansetron compared with high-dose metoclopramide in prophylaxis of acute and delayed cisplatin-induced nausea and vomiting. A multicenter, randomized, double-blind, crossover study. Ann Intern Med 113:834-840, 1990
13. Kris MG, Gralla RJ, Clark RA, et al: Dose-ranging evaluation of the serotonin antagonist GRC507/75 (GR38032F) when used as an antiemetic in patients receiving anticancer chemotherapy. J Clin Oncol 6:659-662, 1988
14. Grunberg SM, Stevenson LL, Russell CA et al: Dose ranging phase I study of the serotonin antagonist GR38032F for prevention of cisplatin-induced nausea and vomiting. J Clin Oncol 7:1137-1141
15. VonHoff DD, Schilsky R, Reichert CM, et al: Toxic Effects of cis-Dichlorodiammineplatinum (II) in Man. Cancer Treat Rep 63:1527-1531, 1979
16. Pritchard JF, Wells CD: Relationship between ondansetron systemic exposure and antiemetic efficacy and safety in cancer patients receiving cisplatin. Pharmacology (in press)
17. Grunberg SM, Groshens, Robinson DC et al: Correlation of anti-emetic efficacy and plasma levels of ondansetron. Eur J Cancer 26:879-882, 1990
18. Hesketh PJ, Twaddell T, Finn A: A possible role for cisplatin (DDP) in the transient hepatic enzyme elevations noted after ondansetron administration. Proc Am Soc Clin Oncol 9:323, 1990 (abstr)