FOLFIRI and Sunitinib in Metastatic Colorectal Cancer

Inclusion Criteria:

* Adult males and females: over 18 years of age.
* Patients with histologically or cytologically confirmed colorectal cancer who will receive their first palliative treatment.
* Patients who have at least one measurable hepatic lesion of 2 cm or more according to RECIST criteria.
* ECOG 0 or 1.
* Signed written informed consent.
* White blood cell count (WBC)\>= 4x10\^9/L with neutrophils \>= 1.5 x 10\*9/L, platelet count \>= 100x10\*9/L, hemoglobin \>= 5.6 mmol/L (10 g/dL).
* Total bilirubin =\< 2 x upper limit of normal.
* AST and ALT =\< 2.5 x upper limit of normal, or =\< 5 x upper limit of normal in case of liver metastases.
* Serum creatinine =\< 1.5 x upper limit of normal or creatinine clearance \> 60 ml/min
* Normal ECG without QT prolongation.

Exclusion Criteria:

* Resectable liver metastasis.
* Adjuvant therapy with FOLFOX or 5-FU / Capecitabine =\< 6 months prior to treatment on study or any previous palliative chemotherapy..
* Any contraindication for FOLFIRI chemotherapy regimen.
* Any investigational drug within the 30 days before inclusion.
* Prior use of sunitinib or other multitarget tyrosine kinase inhibitors or VEGF pathway directed treatments like bevacizumab.
* Known or suspected allergy or hypersensitivity reaction to any of the components of study treatments.
* Pregnancy (absence to be confirmed by beta-hCG test) or lactation period
* Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial
* Clinically symptomatic brain or meningeal metastasis. (known or suspected)
* Cardiac arrhythmias requiring anti-arhythmics (excluding beta blockers or digoxin).
* History of any of the following cardiac events within the past 6 months:

  * myocardial infarction (including severe/ unstable angina),
  * coronary/peripheral artery bypass graft,
  * congestive heart failure (CHF),
  * cerebrovascular accident,
  * transient ischemic attack pulmonary embolism.
* History of clinically significant bleeding within the past 6 months, including gross hemoptysis or haematuria, or underlying coagulopathy.
* History of peptic ulcer disease, deep vein thrombosis, or other significant thrombo-embolic event within the past 6 months.
* Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of \>= 3 anti-hypertensive drugs.
* Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea.
* Previous malignancy (other than colorectal cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor \[Ta, Tis and T1\].
* History of organ allograft
* Treatment with potent CYP3A4 inhibitor within 7 days of sunitinib/placebo dosing or with potent CYP3A4 inducer within 12 days of sunitinib/placebo dosing.
* Prior full field radiotherapy =\< 4 weeks, or limited field radiotherapy, =\< to 2 weeks prior to study enrollment; or previous radiation treatment \>30% of the bone marrow.
* Major surgical procedure, open biopsy or significant traumatic injury within 4 weeks before starting treatment; anticipation of need for major surgical procedure (e.g. impending bowel obstruction) during the course of the study.
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment, unless affected area has been removed surgically.
* Significant disease which, in the investigator's opinion would exclude the patient from the study.
* Patients with seizure and epileptic disorder or other conditions requiring medication such as phenytoin, carbamazepin, phenobarbital.
* Patients requiring long-term cortisone therapy.
* Patients requiring oral anticoagulation treatment (marcoumar).
* Known alcohol or drug abuse.
* Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.