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

Table 2 Patient characteristics

Characteristics	n
Median age (Range) (yr)	62 (51-75)
Sex
Male	7
Female	5
ECOG performance status
0–1	8
2	4
CEA level (range) (ng/mL)	882 (21-6327)
Primary site
Colon	10
Rectum	2
Sites of metastasis
Liver	9
Lung	7
Lymph nodes	6
Others	5
K-Ras status
Wild-type	9
Mutated	3

Table 3 Observed toxicity according NCI-CTC grading (n = 12)

	NCI-CTC grade
	1	2	3	4
Hematological
Anemia	1	3
Leucopenia		2	4
Neutropenia		2	4
Thrombocytopenia		1	2
Non hematological
Nausea/vomiting	2	5
Mucositis	3	4	2
Diarrhea		5	2
Proteinuria		1
Asthenia	3	5
High blood pressure		3