Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC

Sponsor
Alchemia Oncology
Study ID
NCT01290783
Phase
PHASE3
Status
Unknown

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irintoecan — DRUG
    * 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 — DRUG
    * 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.

Study Details

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.

Key Dates

Start date
Dec 31, 2011
Status verified
Aug 2014
Primary completion
Oct 31, 2014
Completion
Dec 31, 2015

Study Design

Enrollment
390 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: FOLFIRI
  • Experimental: FOLF(HA)iri

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Approximately 20 months ]

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