This single arm study will assess the efficacy and safety of a combination of modified FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan 180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of 400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is \<100 individuals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
5mg/kg iv on day 1 of each 2 week cycle
180mg/m2 iv on day 1 of each 2 week cycle
200mg/m2 iv on day 1 of each 2 week cycle
Unnamed facility
Salvador, Brazil
Unnamed facility
São Paulo, Brazil
Unnamed facility
Sorocaba, Brazil
Progression-free survival
Time frame: 12 months
Objective response rate, rate of resection of hepatic metastases, overall survival.
Time frame: Event driven
AEs, laboratory parameters.
Time frame: Throughout study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
400mg/m2 iv on day 1 of each 2 week cycle
Loading dose of 400mg/m2 iv followed by 250mg/m2 iv on day 3 of each 2 week cycle