Overview

SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial

Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label, randomized, phase 2, two-arm clinical trial to be conducted in the United States. Approximately 210 eligible KRAS wild-type expressing metastatic colorectal cancer subjects who have failed first-line oxaliplatin-based chemotherapy (with at least 4 doses of oxaliplatin-based chemotherapy) with at least 4 doses of bevacizumab (failure is defined as toxicity due to oxaliplatin-based chemotherapy or progression of disease on first-line treatment) will be randomized in a 1:1 ratio to receive either a once-every-two-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg or a Q2W FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care).
Phase:
Phase 2
Details
Lead Sponsor:
Amgen
Treatments:
Antibodies, Monoclonal
Bevacizumab
Fluorouracil
Irinotecan
Leucovorin
Panitumumab