Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC

PHASE3UnknownINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

October 31, 2014

Study Completion Date

December 31, 2015

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

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."

DRUG

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."

Trial Locations (5)

2500

Southern Medical Day Care Centre, Wollongong

3011

Western General Hospital, Melbourne

3050

Royal Melbourne Hospital, Melbourne

3165

Monash Medical Centre, Melbourne

3690

Border Medical Oncology, Wodonga

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alchemia Oncology

INDUSTRY