Open label Phase II study of FOLFIRI + Panitumumab using ultra-selection technology with next generation high sensitivity genotyping of patients with stage IV colorectal cancer refractory to irinotecan without any mutation on KRAS, PIK3Ca, BRAF and NRAS genes detected with highly sensitive techniques.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Panitumumab 6,0 mg/kg day 1 i.v. 60 min
Irinotecan 180 mg/m2 day 1 i.v. 30-90 min Folinic acid 400 mg/ m2 day 1 i.v. 120 min 5-FU 400 mg/ m2 day 1 Bolus 5-FU 2.400 mg/ m2 day 1 i.v. 46 hours
Spanish Cooperative Group for Digestive Tumour Therapy
Madrid, Spain
Objective response rate (TRO)
Time frame: 4 years
disease control rate (TCE)
Time frame: 4 years
duration of response (DR)
Time frame: 4 years
time to response(THR)
Time frame: 4 years
time to progression (THP)
Time frame: 4 years
time to treatment failure (THF)
Time frame: 4 years
duration of stable disease (DEE)
Time frame: 4 years
Progression free survival (SLP)
Time frame: 4 years
Overall survival (SG)
Time frame: 4 years
Adverse events
Time frame: 4 years
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