Randomized Double-blind Phase III Trial of FOLF(HA)Iri vs FOLFIRI for Second or Third Line Therapy in Irinotecan-naïve Patients With Metastatic Colorectal Cancer (FOLF(HA)iri)

NCT01290783 Phase 3 UNKNOWN

Trial design: * Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with "Hyaluronic acid-Irinotecan" or "HA-Irinotecan") regimen. * Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve. * Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria, Poland, Serbia, Russia, Ukraine and the United Kingdom). * Dosing regimen: * Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in patients \> 75 years of age, the irinotecan and HA-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-fluorouracil (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 2 weeks for 8 months. * Patient accrual over approximately 12-14 months. * Monitoring to 18 months post-randomization. * 390 patients. * Progression Free Survival (PFS) primary endpoint. * Safety analysis on the initial 20 patients.

Details

Lead sponsor	Alchemia Oncology
Phase	Phase 3
Status	UNKNOWN
Enrolment	390
Start date	2011-12
Completion	2015-12

Conditions

• Metastatic Colorectal Cancer

Interventions

• Irintoecan
• HA-Irinotecan solution for Infusion

Primary outcomes

• Progression Free Survival (PFS) — Approximately 20 months

Countries

Australia