583
Participants
Start Date
March 8, 2012
Primary Completion Date
November 23, 2015
Study Completion Date
April 27, 2016
Irinotecan Injection [Camptosar]
CPT-11 will be administered according to UGT1A1 genotypes. Patients with UGT1A1 \*1/\*1 or heterozygous UGT1A1\*1/\*28 or \*1/\*6 will receive standard dose of CPT-11. Patients with homozygous UGT1A1\*28/\*28, \*6/\*6 or \*28/\*6, will be randomized in a 1:1 ratio to receive standard dose of CPT-11 or 50% reduced dose of CPT-11.
5-fluorouracil
The 5-FU dosage will remain the standard.
Leucovorin
The LV dosage will remain the standard.
Affiliated Hospital Cancer Center, Academy of Military Medical Sciences (307 Hospital of PLA), Beijing
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
OTHER