This study will evaluate the efficacy of Irinotecan,Capecitabine and Avastin combination in patients with no response to previous treatment with 5-Fluorouracil,Leucovorin,Eloxatin and Avastin.
The aim of this phase II study is to evaluate the efficacy of the combination XELIRI/AVASTIN in patients with mCRC, who have progressed in first line treatment with FOLFOX/AVASTIN. For AVASTIN was selected the dosing schedule of the trials TREE 1 and 2 \[17\], where Avastin was combined with capecitabine and oxaliplatin in a three weeks schedule and with adaptation of the dose in the 7,5 mg/kg
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Capecitabine 2000 mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
Bevacizumab 7.5 mg/kg intravenous (IV) on day 1 every 3 weeks for 6 cycles
Irinotecan 250 mg/m2 IV on day 1 every 3 weeks for 6 cycles
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Greece
Objective Response Rate
Time frame: up to 6 months
Time To Progression
Time frame: 1 year
Toxicity profile
Time frame: Toxicity assessment on each chemotherapy
Quality of life
Time frame: Assessment every two cycles
Symptoms improvement
Time frame: Assessment every two cycles
Overall Survival
Time frame: 1 year
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