title: [A Phase I study of docetaxel and cisplatin for advanced squamous cell carcinoma of the head and neck].
abstract: A Phase I study of docetaxel (DOC) and cisplatin (CDDP) combination therapy was conducted as second-line treatment for advanced squamous cell carcinoma of the head and neck in order to determine the maximum tolerated dose (MTD), the dose-limiting toxicity (DLT) of DOC, and the recommended dose (RD) for this combination therapy. Twenty patients with recurrence for whom failed first-line chemotherapy with CDDP and 5-FU proved in-effective (17 male, 3 female; age range 38-74 years; performance status 0=7, 1 =8, 2=5) were included in this study. DOC at dose level I (40 mg/m2), level II (50 mg/m2), level III (60 mg/m2) and level IV (70 mg/m2) was used, followed by CDDP administration at a fixed dose of 80 mg/m2. Originally, chemotherapy was repeated every 3 weeks. In level I, grade 4 hypokalemia occurred in one patient. No DLT occurred at level II. At level III, one patient experienced grade 4 vomiting. At level IV, grade 2 creatinine clearance decrease occurred in a total of two patients. The maximum tolerated dose in this combination therapy was DOC 70 mg/m2, and CDDP 80 mg/m2. The recommended dose for this combination therapy is DOC 60 mg/m2, and CDDP 80 mg/ m2. A multicenter cooperative phase II study in this RD is recommended.
authors.affiliation: Dept of Head and Neck Surgery, Aichi Cancer Center Hospital.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Ogawa
authors.forename: Akihiro
authors.initials: A
authors.lastname: Terada
authors.forename: Ikuo
authors.initials: I
authors.lastname: Hyodo
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ando
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Suzuki
authors.forename: Taijiro
authors.initials: T
authors.lastname: Ozawa
authors.forename: Yasuhisa
authors.initials: Y
authors.lastname: Hasegawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008175:Lung Neoplasms / Q000556:secondary; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000209:etiology; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin