10-hydroxy-camptothecin plus fluorouracil/leucovorin for the treatment of patients with advanced colorectal cancer
Zhang, H.-G.; Cai, R.-G.; Chen, S.-S.; Wu, F.; Chu, D.-T.
Zhonghua Yi Xue Za Zhi 87(21): 1462-1464
2007
ISSN/ISBN: 0376-2491 PMID: 17785082 Document Number: 610369
To evaluate the maximum tolerated dose and dose-limiting toxicity (DLT) of 10-hydroxy-camptothecin (10-HCPT) in HFL regimen for the treatment of advanced colorectal cancer (CRC). 18 advanced CRC patients, 13 males and 3 females, aged 33 - 70, were randomly assigned to 6 groups to be treated with 10-HCPT 4, 6, 8, 10, 12, or 14 mg/m(2), and 5-fluoro-uracil (5-FU) 425 mg/m(2), and leucovorin (LV) 20 mg/m(2), all administered intravenously on days 1 - 5 with 4 weeks as one cycle. The efficacy and side-effect were evaluated. There were two patients with grade IV myelosuppression in the 10, 12, and 14 mg/m(2) groups each. The most dose-associated adverse reactions were myelosuppression and GI dysfunction. The DLT was myelosuppression, and the maximum tolerable dose of 10-HCPT is 10 mg/m(2) on days 1 - 5. HFL regimen is well tolerated in the patients with advanced CRC. The dosing regimen recommended in clinic trial is 8 mg/m(2).