390
Participants
Start Date
December 31, 2011
Primary Completion Date
October 31, 2014
Study Completion Date
December 31, 2015
Irintoecan
"* Irinotecan, 180 mg/m2 IV, over 90 minutes, day 1 (in patients \> 75 years of age, the irinotecan dose in must be reduced to 150 mg/m2).~* Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.~* 5-FU, 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.~* Repeat every two weeks.~* 8 months of treatment."
HA-Irinotecan solution for Infusion
"* HA-Irinotecan (irinotecan 180 mg/m2), IV, over 90 minutes, day 1 (in patients \> 75 years of age, the irinotecan dose in must be reduced to 150 mg/m2).~* Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.~* 5-FU, 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.~* Repeat every two weeks~* 8 months of treatment."
Southern Medical Day Care Centre, Wollongong
Western General Hospital, Melbourne
Royal Melbourne Hospital, Melbourne
Monash Medical Centre, Melbourne
Border Medical Oncology, Wodonga
Lead Sponsor
Alchemia Oncology
INDUSTRY