Randomized Phase 3 Study on the Optimization of Bevacizumab With mFOLFOX/mOXXEL in the Treatment of Patients With Metastatic Colorectal Cancer
Inclusion Criteria:
- Histological diagnosis of colorectal adenoma carcinoma
- Stage IV disease
- Presence of at least one measurable target lesion (according to RECIST), and not
previously radiated.
- Age ≥ 18 e ≤ 75 years
- ECOG Performance status 0-1
- Life expectancy >3 months
- Adequate recovery from surgery, with at least 28 days from surgery to date of
pre-study biopsy.
- Adequate contraception for male and female patients of child bearing potential
- informed consent
Exclusion Criteria:
- More than one previous line of therapy for metastatic disease
- Prior treatment with bevacizumab or oxaliplatin (previous treatment with irinotecan,,
cetuximab, fluoropyrimidine, folic acid are permitted)
- Primary tumor that is stenosing and/or that infiltrates the entire thickness of the
intestinal wall
- Regular use of NSAIDs or aspirin
- Bleeding disorders or coagulopathy
- Concurrent anticoagulant therapy
- Suspected or cerebral metastases (to verify in the presence of symptoms)
- Neutrophils < 2000 / mm3, platelets < 100,000 / mm3, hemoglobin < 9g/dl
- Creatinine > 1.5 times the upper normal limit
- GOT and/or GPT > 2.5 times the upper normal limit, bilirubin > 1.5 times the upper
normal limit in absence of liver metastases
- GOT and/or GPT > 5 times the upper normal limit, bilirubin > 3 times the upper normal
limit in presence of liver metastases
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with
the exception of basal and squamous cell carcinoma or cervical cancer in situ
- Congestive heart failure, ischemic coronary events within past 12 months,
uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Active or uncontrolled infection
- Any concomitant condition that, in the investigator's opinion, would contraindicate
the use of any of the study drugs
- Pregnancy or lactation
- Central nervous system disorders or peripheral neuropathy > grade 1 (CTCAE v. 4.0)
- Inability to comply with follow up procedures of the study