At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicentre Randomised Phase II Study to Assess the Safety and Resectability in Patients With Initially Unresectable Liver Metastases Secondary to Colorectal Cancer Receiving First-line Treatment Either With mFOLFOX-6 Plus Bevacizumab or FOLFOXIRI Plus Bevacizumab (OLIVIA)
In Brief
A Phase 2 clinical trial evaluating 5-FU, Irinotecan, and 3 other interventions for Colorectal Cancer. Completed, enrolled 80 participants across 19 sites in 4 countries.
Detailed Summary
This 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresectable liver metastases receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment is until surgery, disease progression, unacceptable toxicity or patient refusal, and the target sample size is \<100 individuals.
Study Details
Timeline
Interventions
Bolus 400mg/m2, day 1 every 2 weeks
3200mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks
2400mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks
165mg/m2 1-hour iv infusion, day 1 every 2 weeks
400mg/m2 2-hour iv infusion, day 1 every 2 weeks
200mg/m2 2-hour iv infusion, day 1 every 2 weeks
85mg/m2 2-hour iv infusion, day 1 every 2 weeks
5mg/kg iv day 1 every 2 weeks