Sirolimus, bevacizumab, 5-Fluorouracil and irinotecan for advanced colorectal cancer: A pilot study

Table 1 Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Histologically confirmed colorectal cancer (adenocarcinoma)	Thromboembolism that required therapeutic anticoagulation
Measurable disease	Central nervous system metastasis
No secondary malignancy	Major surgery within 6 wk
Age > 18 years	Nonhealing wounds
ECOG performance status 0-2	Uncontrolled hypertension
Adequate hematological, hepatic and renal function (including urinary excretion of no more than 500 mg protein/d)	Pregnant or lactating women
Failure of bevacizumab, oxaliplatin and irinotecan-based treatment	Bleeding diathesis, active or recent
For wild-type K-Ras: failure with cetuximab and irinotecan combination was required	Cardiovascular disease
Failure caused by significant intolerance to either drug was allowed	Cerebrovascular accident