Selecting Treatment in Colorectal Cancer:Capecitabine or 5-fluorouracil Selection to be Combined With Oxaliplatin or Irinotecan as First-line Chemotherapy in Advanced Colorectal Cancer
Selecting Treatment in Colorectal Cancer:Capecitabine or 5-fluorouracil Selection to be Combined With Oxaliplatin or Irinotecan as First-line Chemotherapy in Advanced Colorectal Cancer
The purpose of the study is to evaluate the efficacy and safety of the capecitabine or
 5-fluorouracil selection, according to polymorphisms in TS-3'UTR and ERCC1-118, to be
 combined with oxaliplatin or irinotecan as first-line chemotherapy in advanced colorectal
 cancer
Inclusion Criteria:

 -  informed consent signed

 -  Histological or citological adenocarcinoma confirmation carcinoma on the colon or
 colorectal metastatic or relapsed patients with adenocarcinoma of colon or recto,
 confirmed histologically with metastatic disease

 -  measurable disease (following RECIST criteria)

 -  ECOG ≤ 2

 -  older or equal 18 years old

 -  life expectancy superior to 3 months

 -  Adequate or moderate renal function: renal function (Creatinine clearance > 30mL/min),
 based on Cockroff - Gault.

 -  Potential fertile women negative pregnancy test in serum or urine, 10 days prior the
 first study dose given

 -  Use an adequate contraceptive method

 Exclusion Criteria:

 -  Patients treated previously with Bevacizumab

 -  Non measurable lesion as only disease evidence

 -  Previous chemotherapy treatment for adjuvant or neoadjuvant disease (no metastatic
 (M0), or immunotherapy active/passive for the advance or metastatic disease. It is
 permitted the adjuvant or neoadjuvant treatment it is has finished at least 6 months
 before the initiation of the study drug.If the patient has received an adjuvant
 treatment previously the patient cannot participate if disease progression has been
 confirmed during the treatment or on the 6 months later

 -  Prior radiotherapy is allowed if it has not been administered in the target lesions
 selected for this study, unless progression of said lesions in the irradiated field is
 documented, and as long as treatment has concluded at least 4 weeks before beginning
 the study.

 -  Prior surgical treatment of the disease in stage IV is allowed

 -  Functional dependency

 -  Previous serious adverse events or unexpected to fluoropyrimidine treatment and /o
 patients with proved deficit in dehidropirimidin dehydrogenase (DPD)

 -  Patients classified as "weak or fragile"

 -  Cardiac concomitant present: Symptomatic auriculoventricular arrhythmia history, and /
 cardiac arrhythmias requiring medication or peripheral vascular disease, grade II or
 higher. Furthermore, those patients who have had a myocardial infarction in the year
 prior to beginning the treatment of the study will be excluded.

 -  History of another neoplastic disease during the last five years, with the exception
 of cured basal cell carcinoma of the skin and cervical carcinoma in situ.

 -  History or indications of CNS disease in the physical examination.

 -  History of psychiatric disability that the investigator considers clinically
 significant, which prevents the patient from granting the informed consent or
 interferes with compliance of taking the oral medication.

 -  Uncontrolled hypertension or clinically significant (i.e. active) cardiovascular
 disease: CVA/stoke (≤ 6 months prior to randomisation), myocardial infarction (≤ 6
 months prior to randomisation), unstable angina, New York Heart Association (NYHA,)
 Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring
 medication.

 -  Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome
 or inability to take oral medication.

 -  Patients subjected to organ allograft who require immunosuppressive treatment.

 -  Severe, non-cicatrized osseous fractures, wounds or ulcers

 -  Indications of hemorrhagic diathesis or coagulopathy.

 -  Severe, uncontrolled intercurrent infections or other severe, uncontrolled concomitant
 diseases.

 -  Any of the following laboratory values:

 1. Absolute neutrophil count (ANC) < 1.5 x 109/l

 2. Platelet count < 100 x 109/l

 3. Hemoglobin < 10 g/dl (it can be transfused to maintain or exceed this level)

 4. International Normalized Ratio (INR) > 1.5

 5. Total bilirubin > 1.5 times the upper limit of normal (ULN)

 6. ALAT, ASAT > 2.5 x ULN or > 5 x (ULN) in the case of hepatic metastases

 7. Alkaline phosphatase > 2.5 x ULN or > 5 x ULN in the case of hepatic metastases
 or > 10 x ULN in the case of osseous metastases.

 -  Patients subjected to a major surgical procedure, open biopsy or who have had
 significant traumatic lesions within the 28 days prior to beginning the treatment of
 the study or in whom it is foreseen that a major surgical procedure will be necessary
 during the course of the study; fine-needle aspiration within the 7 days prior to
 beginning the treatment of the study.

 -  Current or recent use (within the 10 days prior to beginning the treatment of the
 study) of oral or parenteral anticoagulants at complete doses or thrombolytic agents.
 The use of low doses of warfarin is allowed, with an International Normalized Ratio
 [INR] of < 1.5.

 -  Daily chronic treatment with high doses of aspirin (> 325 mg/day) or non-steroid
 anti-inflammatory medications (which inhibit the platelet function at doses used for
 treating chronic inflammatory diseases).

 -  Patients who have received any drug or agent/procedure under research, i.e., who have
 participated in another clinical trial during the 4 weeks prior to beginning the
 treatment with the medications of the study.

 -  Pregnancy or lactating woman. Woman with reproductive potential unless using an
 effective method of contraception (Postmenopausal woman must have been amenorrheic
 during at least 12 months).

 -  Known hypersensitivity to any of the study drugs or excipients of the Bevacizumab or
 to Chinese hamster ovary cell products or to other recombinant human or humanised
 antibodies.