Irinotecan, Cetuximab and Everolimus to Patients With Metastatic Colorectal Cancer

Criteria for inclusion:

* Patients with a histological or cytological verified adenocarcinoma of the colon or rectum with non-resectable or metastatic cancer.
* Patients with measurable disease without previous radiotherapy
* Patients with metastatic colorectal cancer with progression after previous therapy with 5-fluoropyrimidines, oxaliplatin or irinotecan. Patients should have been treated with oxaliplatin, but if oxaliplatin has be contraindicated or not tolerated the patient can participate in the trial.
* Patients with KRAS-mutation in their primary tumour or metastasis.
* Patients with progression after therapy with irinotecan or cetuximab independent of KRAS mutation status.
* Previous radiotherapy is allowed to less than 25 % of the bone marrow.
* Age more or equal to 18 years.
* Performance status less than 3.
* An expected survival time of at least 3 months.
* Signed informed consent according to specifications from the ethical comites.

Criteria for exclusion:

* Former or other concurrent malignant disease except treated basal cell carcinoma or in situ cervical cancer.
* No cytotoxic therapy or other experimental treatment within 28 days before inclusion.
* No former therapy with everolimus or other rapamycin as sirolimus or temsirolimus.
* No known hypersensitivity for one or more components in the therapy.
* No uncontrolled diabetes
* No serious non-healing wounds, gastric ulcers, bone fractures, greater surgical procedures, major traumatic injuries within 28 days before inclusion.
* No ongoing bleeding or pathological condition associated with a risk of bleeding.
* No liver disease as cirrhose, chronical active hepatitis or chronic persistent hepatitis.
* No gastrointestinal disturbances in function that might cause a major change in the absorption of everolimus as ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome.
* No planned immunisation with attenuated virus in the study period.
* Patients that is unable to follow treatment or evaluation plan.
* Every condition or therapy that after the judgement of investigator might infer the patient a risk or influence the trials objective.
* Pregnant or breastfeeding women.
* At fertile women this is insured by a negative test of pregnancy or use of a safe anticonception during the trial period and at least 3 months after end of treatment.
* Patients with active infections or other serious medical co-morbidity, that might prevent the patient from being treated with the protocoled therapy.
* Incapacitated