Multicenter phase I trial of induction chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma.
A phase I study of combination neoadjuvant chemotherapy with docetaxel (DOC) and nadaplatin (CDGP) was conducted in patients with untreated, advanced but operable oral squamous cell carcinoma. DOC was administered (one-hour i.v. infusion) on day 1 followed by CDGP (one-hour i.v. infusion). The dose levels of DOC and CDGP tested were 60/70, 60/80, 60/90, 60/100, and 70/100 (mg/m(2)). Fifteen patients enrolled in this study and median age was 60 years. Dose-limiting toxicity (DLT) occurred in one of six patients at DOC dose of 60 mg/m(2) and CDGP dose of 100 mg/m(2). The DLT was diarrhea. Because one additional patient at this dose-level developed grade 4 neutropenia lasting for 4 days that approached DLT and because fear of severe hematological problems was predicted, further dose escalation was not performed. This combination chemotherapy is active and well tolerated and warrants a phase II study. We recommended 60 mg/m(2) DOC and 100 mg/m(2) CDGP for phase II study.
Kurita
Hiroshi
H
Department of Dentistry and Oral Surgery, Shinshu University School of Medicine, 3-1-1, Asahi, Matsumoto 390-8621, Japan.
Yamamoto
Etsuhide
E
Nozaki
Shinichi
S
Wada
Shigehito
S
Furuta
Isao
I
Kurashina
Kenji
K
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D012074:Remission Induction; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D009944:Organoplatinum Compounds; D043823:Taxoids; D000077143:Docetaxel; C053989:nedaplatin