title: A phase I trial of docetaxel based induction and concomitant chemotherapy in patients with locally advanced head and neck cancer.
abstract: The purpose of this study was to determine the maximum tolerated dose (MTD) of docetaxel based induction and concomitant chemoradiotherapy (CRT) after using the FHX platform (5 = 5-FU, H = hydroxyurea, X = Radiation). Patients with Stage III/IV locally advanced HNSCC were enrolled. Induction chemotherapy (carboplatin/docetaxel) was followed by 5 cycles of concomitant docetaxel based CRT. No DLTs were observed in dose levels 1/2 for induction and CRT. Dose level 2 was expanded. The overall survival CR rate after CRT was 79 percent. Median overall (OS) has not been reached and 2-year OS is 80.7 percent. The recommended Phase II dose of docetaxel with FHX CRT is 25 mg/m(2) and 35 mg/m(2) in combination with carboplatin induction (AUC = 6).
authors: Section of Hematology/Oncology, University of Chicago, Chicago, Illinois 60637, USA.
authors: Tanguy Y
authors: TY
authors: Seiwert
authors: Ezra E W
authors: EE
authors: Cohen
authors: Daniel J
authors: DJ
authors: Haraf
authors: Kerstin
authors: K
authors: Stenson
authors: Elizabeth A
authors: EA
authors: Blair
authors: Ann
authors: A
authors: Mauer
authors: Allison
authors: A
authors: Dekker
authors: Everett E
authors: EE
authors: Vokes
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D005472:Fluorouracil; D006918:Hydroxyurea