Metastatic Colorectal Cancer Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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