A phase I trial of docetaxel based induction and concomitant chemotherapy in patients with locally advanced head and neck cancer.
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).
Seiwert
Tanguy Y
TY
Section of Hematology/Oncology, University of Chicago, Chicago, Illinois 60637, USA.
Cohen
Ezra E W
EE
Haraf
Daniel J
DJ
Stenson
Kerstin
K
Blair
Elizabeth A
EA
Mauer
Ann
A
Dekker
Allison
A
Vokes
Everett E
EE
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
D043823:Taxoids; D000077143:Docetaxel; D005472:Fluorouracil; D006918:Hydroxyurea