A multicentre two-part phase I/II study evaluating response and safety of SORAFENIB in combination with irinotecan in the second line treatment or more of metastatic colorectal cancer with K-RAS mutation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Sorafenib administrated continuously orally 400 mg twice daily (a daily total dose of 800 mg). Irinotecan 180 mg/m² will be administered IV for 90 minutes every 2 weeks. The first dose of sorafenib will be administered after the first perfusion of irinotecan 180 mg/m² at the first infusion
Centre Oscar Lambret
Lille, France
Hopital Saint Eloi
Montpellier, France
Centre Rene Gauducheau
Nantes, France
Centre Antoine Lacassagne
Nice, France
CHU Robert Debre
Reims, France
disease control
Time frame: 6 months
Assessment of adverse events by using the NCI-CTCAE version 3 scale
Time frame: 6 months
progression free survival
Time frame: 24 months
overall survival
Time frame: 36 months
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