This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Patients will receive up to 12 bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
3200mg/m2 continuous iv infusions, day 1 every 2 weeks
5mg/kg iv infusion, day 1 every 2 weeks
165mg/m2 iv infusion, day 1 every 2 weeks
200mg/m2 iv infusion, day 1 every 2 weeks
85mg/m2 iv infusion, day 1 every 2 weeks
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Bochum, Germany
Unnamed facility
Celle, Germany
Unnamed facility
Celle, Germany
Unnamed facility
Dessau, Germany
Unnamed facility
Freiburg im Breisgau, Germany
Unnamed facility
Fulda, Germany
Unnamed facility
Hamburg, Germany
Unnamed facility
Hamburg, Germany
...and 7 more locations
Progression-free survival
Time frame: assessed every 8 weeks up to week 102, 3-monthly during follow-up
Overall survival; proportion of patients achieving R0 resectability; objective response rate (complete response [CR] and partial response [PR]); proportion of patients completing 12 cycles of chemotherapy.
Time frame: assessed every 4 weeks up to week 102 and at the end of follow-up period
Proportion of patients with NCI-CTC grade 3-5 adverse events; adverse events, laboratory parameters, ECOG performance status.
Time frame: Throughout study, laboratory analyses every 2 weeks, ECOG assessment every 8 weeks
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