A phase I study of continuous administration of 5-fluorouracil/cisplatin in advanced uterine cervical cancer.
BACKGROUND
The aim of this study was to assess the toxicity of a neoadjuvant chemotherapy (NAC) regimen consisting of cisplatin (CDDP) and 5-fluorouracil (5-FU) through 24-hour intravenous continuous infusion on days 1-4 in a Phase I study.


METHODS
Thirteen patients were recruited for this study. All patients were treated with a regimen consisting of CDDP and 5-FU through a 24-hour intravenous continuous infusion on days 1-4, followed by radical hysterectomy and/or radiation. Each initial dose of CDDP and 5-FU was 20 mg/m2/day and 750 mg/m2/day, respectively, for 4 days.


CONCLUSIONS
In the third step, seven patients were treated at 25 mg/m2 day CDDP and 1000 mg/m2/day 5-FU, respectively, for 4 days. One of seven patients showed Grade 4 thrombopenia. However, in this dose step, all the patients showed an objective response. Although maximum tolerated doses (MTDs) were not reached, we decided to stop the escalation and to recommend this level for the Phase II study.
Yoshida
Yoshio
Y
Department of Obstetrics and Gynecology, Fukui Medical University, Matsuoka-Cho, Yoshida-Gum, Fukui 910-1193, Japan. yyoshida@fmsrsa.fukui-med.ac.ip
Goto
Kenji
K
Kawahara
Kazumi
K
Kurokawa
Tetuji
T
Shukunami
Kenichi
K
Kotsuji
Fumikazu
F
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
D002945:Cisplatin; D005472:Fluorouracil