[Phase I clinical trial evaluation of capecitabine in concurrent combination of radiotherapy in nasopharyngeal carcinoma].
OBJECTIVE
Capecitabine is an oral fluoropyrimidine, which is converted to fluorouracil (5-FU) by exploiting the comparatively higher activity of thymidine phosphorylase (TP) in tumor tissue. This study was designed to measure the maximum tolerated dose (MTD) of capecitabine in the patients with nasopharyngeal carcinoma.


METHODS
Medical records of 36 patients with nasopharyngeal carcinoma treated with radiation and capecitabine were reviewed. The median dose of capecitabine was 1 600 mgx(m(2)xd)(-1) [700-2 500 mgx(m(2)xd)(-1)] orally for 2 weeks followed 1 week of rest and then another cycle. All the patients received a total dose ranging from 66 Gy to 74 Gy over 6-7.4 weeks.


RESULTS
In the 2 300 mgx(m(2)xd)(-1) group, Grade III toxicities observed were hang-foot syndrome (1 patient) and diarrhea (1 patient).


CONCLUSIONS
Concurrent administration of capecitabine and radiation were tolerable in the patients with nasopharyngeal carcinoma. The maximum tolerated dose is 2 300 mgx(m(2)xd)(-1), The recommended phase II dose is 1 700 mgx(m(2)xd)(-1) daily administered by this intermittent schedule.
Jiang
Yong
Y
Department of Nasopharyngeal Carcinoma, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong, 510060, PR China.
Hong
Ming-Huang
MH
Deng
Man-Quan
MQ
Guo
Ling
L
Cao
Ka-Jia
KJ
Mo
Hao-Yuan
HY
Qiu
Fang
F
Mai
Hai-Qiang
HQ
Chen
Qiu-Yan
QY
Sun
Rui
R
Luo
Dong-Hua
DH
Huang
Pei-Yu
PY
D000328:Adult; D000368:Aged; D000069287:Capecitabine; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000628:therapy*; D011879:Radiotherapy Dosage
D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil