[Phase II clinical trial of oxaliplatin alone for refractory advanced colorectal cancer].
OBJECTIVE
Oxaliplatin is effective for the advanced colorectal cancer (CRC) as a second-line drug; however, the efficiency and adverse reaction of oxaliplatin made in China are not yet clear. The aim of this project was to evaluate the efficacy and the toxicities of oxaliplatin made in China in the treatment of the patients with advanced CRC who were resistant to 5-fluorouracil (5-Fu).


METHODS
The previously 5-FU-resistant patients with CRC were treated with single agent of oxaliplatin 130 mg/m(2), i.v., d1, repeated every 3 weeks.


RESULTS
A total of 31 cases with advanced CRC resistant to 5-Fu were enrolled, and 28 cases were valuable for efficacy assessment. One patient reached complete response (CR), 3 reached partial response (PR), and the overall response rate was 14.29% (with ITT equal to 12.9%). The major adverse effects were mild neuro-sensory toxicity, mild myelosuppression,and nausea/vomiting.


CONCLUSIONS
The oxaliplatin made in China is effective in the treatment of advanced CRC resistant to 5-Fu, and the adverse effects are mild.
Xu
Rui-Hua
RH
Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong, 510060, PR China. ruihuaxu@163.net
Guan
Zhong-Zhen
ZZ
Feng
Feng-Yi
FY
He
Xiao-Hui
XH
Liu
Shu-Jun
SJ
Di
Li-Jun
LJ
Li
Shu-Fen
SF
Li
Li-Qing
LQ
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000077150:Oxaliplatin
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin