Phase I study of capecitabine, carboplatin and intensity-modulated radiation therapy for head and neck cancer.
BACKGROUND
To determine the maximally tolerated dose (MTD) of capecitabine when given concomitantly with carboplatin and intensity-modulated radiation therapy (IMRT) for treatment of localized stage III/IV squamous cell carcinomas of the head and neck (HNSCC).


METHODS
After six weeks of induction chemotherapy with capecitabine and carboplatin, patients received a second course with concomitant IMRT. The MTD for capecitabine during chemoradiation was determined by a standard phase I trial design.


RESULTS
Nine out of the eleven patients qualified for chemoradiation. With weekly carboplatin AUC=1.5 and IMRT, the MTD of capecitabine was 850 mg/m(2)/day when given in divided doses on days 1-14 and 22-35. The dose-limiting toxicity was myleosuppression and other adverse effects were modest. Eight patients experienced complete response after chemoradiation and seven remain relapse-free after 34 months.


CONCLUSIONS
Capecitabine, carboplatin, and IMRT given as described were well tolerated by HNSCC patients and in this pilot study produced a promising rate of disease control.
Thomas
Christopher Y
CY
Division of Hematology/Oncology, University of Virginia Health Sciences Center, Charlottesville, VA 22908, USA. cyt@virginia.edu
Read
Paul
P
Petroni
Gina
G
Reibel
James
J
Levine
Paul A
PA
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D016190:Carboplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D016896:Treatment Outcome
D003841:Deoxycytidine; D000069287:Capecitabine; D016190:Carboplatin; D005472:Fluorouracil