Study of Aflibercept as Maintenance Therapy Following Induction With Aflibercept in Combination With XELOX, as First-Line Treatment for Metastatic Colorectal Cancer Patient

Inclusion criteria:

* Histologically or cytologically-proven adenocarcinoma of the colon or rectum.
* Metastatic disease not amenable to potentially curative treatment (i.e. unresectable).
* Measurable lesion as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* No prior systemic anti-cancer treatment for metastatic disease.
* No prior adjuvant treatment after resection of distant metastases.
* No prior treatment with angiogenesis inhibitors.

Exclusion criteria:

* Age \<18 years.
* Eastern Cooperative Oncology Group Performance status \>/= 2.
* Less than 4 weeks from prior radiotherapy or prior surgery (or until the surgical wound is fully healed).
* Treatment with any other investigational product within the prior 28 days.
* Other prior neoplasm.
* History of brain metastases, active seizure disorder, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
* Any of the following within the prior 6 months: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, severe congestive heart failure, stroke or transient ischemic attack.
* Any of the following within the prior 3 months: moderate/severe gastrointestinal bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic event.
* Deep vein thrombosis within the prior 4 weeks.
* Any severe acute or chronic medical condition, which could impair the ability of the participant to participate in the study.
* Inadequate bone marrow, liver and renal function: neutrophils \< 1.5x10\^9/L, platelets \< 100x10\^9/L, hemoglobin \< 9.0 g/dL, total bilirubin \>1.5 x upper normal limit (ULN), transaminases \>3 x ULN (unless liver metastasis are present), alkaline phosphatase \>3 x ULN (unless liver metastasis are present), serum creatinine \> 1.5 x ULN.
* Participants on anticoagulant therapy with warfarin.
* Symptomatic peripheral sensory neuropathy.
* Inability to take oral medications.
* Prior history of chronic enteropathy, inflammatory enteropathy, chronic diarrhea, malabsorption syndrome, unresolved bowel obstruction/sub-obstruction, surgery more extensive than hemicolectomy, extensive small intestine resection with chronic diarrhea.
* Known dihydropyrimidine dehydrogenase deficiency.
* known history of hypersensitivity to aflibercept.
* Any contraindication to administer oxaliplatin or capecitabine as per package insert of each drug.
* Urine protein-creatinine ratio (UPCR) \>1 on morning spot urinalysis or proteinuria \> 500 mg/24-h.
* Uncontrolled hypertension within the prior 3 months.
* Evidence of clinically significant bleeding predisposition or underlying coagulopathy, non-healing wound.
* Pregnant or breast-feeding women.
* Participants with reproductive potential who do not agree to use an accepted effective method of contraception.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.