A phase I study of prolonged infusion 5-fluorouracil and concomitant radiation therapy in patients with squamous cell cancer of the head and neck.
The radiosensitization properties of 5-FU are well documented, and clinical trials have suggested improved local control and survival in head and neck cancer. Clinical trials to date have used bolus injection or short term (less than or equal to 5 days) 5-FU infusions. To determine the maximum tolerated dose (MTD) of 5-FU given as continuous intravenous infusion for 12 weeks concomitant with conventional radiation therapy, 18 patients with advanced inoperable head and neck cancers were treated with conventional irradiation and 100, 200, 250, or 300 mg/m2/day of 5-FU. A dose of 250 mg/m2/day was determined to be the maximum tolerated dose and is recommended for Phase II studies.
Weppelmann
B
B
Department of Radiation Oncology, University of Alabama, Birmingham 35229.
Wheeler
R H
RH
Peters
G E
GE
Stephens
S
S
Spencer
S A
SA
Meredith
R F
RF
Kim
R Y
RY
Salter
M M
MM
D000328:Adult; D000368:Aged; D002280:Basal Cell Carcinoma / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011879:Radiotherapy Dosage
D005472:Fluorouracil