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

• Conditions: Colorectal cancer metastatic; MedDRA version: 16.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000858-22-IT
• Lead Sponsor: Sanofi-Aventis Groupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-28
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 61
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39

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 patient 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
- Patients 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.
- Patients with reproductive potential who do not agree to use an accepted effective method of contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified