metastatic colorectal cancer MedDRA version: 13.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Aflibercept / VEGF Trap
Product Code: AVE0005
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: aflibercept
Current Sponsor code: AVE0005
Other descriptive
Sponsors
sanofi-aventis recherche et développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria will be considered for enrollment into the study: - Histological proven and advanced/metastatic colorectal cancer not amenable to potentially curative treatment. - Measurable disease (as per RECIST guidelines) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - ECOG Performance status >2 (see Appendix B) - Age 3.0 x ULN (or >5 x ULN in the case of liver function abnormalities due to underlying liver metastases) • Alkaline Phosphatase >3 x ULN (or >5 x ULN if due to underlying liver metastases) • Total bilirubin >1.5 x ULN - Less than 28 days elapsed from prior radiotherapy. - Less than 42 days elapsed from prior major surgery to the time of randomization - Patients with initially resectable liver-only disease - History of another neoplasm, with the exception of adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer, or any other cancer from which the patient has been disease-free for < 5 years. - History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease - Participation in another clinical trial with an investigational drug and any concurrent treatment with any investigational drug within 30 days prior to randomization - Any of the following events =3 months prior to randomization • treatment resistant peptic ulcer disease • erosive esophagitis or gastritis • infectious or inflammatory bowel disease or diverticulitis - Any of the following events =6 months prior to randomization • pulmonary embolism, or other uncontrolled thromboembolic event • myocardial infarction • severe/unstable angina pectoris • coronary/peripheral artery bypass graft surgery • NYHA class III or IV congestive heart failure (see Appendix C) • stroke or transient ischemic attack • grade 3 or 4 gastrointestinal bleeding/hemorrhage except for the primary colon/rectum tumor site that has been resected prior to study randomization - Deep vein thrombosis =4 weeks prior to randomization - Known Acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment - History of hypersensitivity to fluoropyrimidines, or folic acid derivatives - Known dihydropyrimidine dehydrogenase deficiency - Symptomatic peripheral sensory neuropathy grade =2 (NCI-CTCAE v3.0) in patients with no prior oxaliplatin - Symptomatic peripheral sensory neuropathy grade =1 (NCI-CTCAE v3.0) in patients with prior oxaliplatin - Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study or interfere with interpretation of study results - Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization - Patient with reproductive potential (M/F) who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 3 months after the completion of the study treatment. The definition of “effective method of contraception” will be based on the Investigator’s judgment - For female patients enrolled in the UK (unl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to estimate the Progression-Free Survival (PFS) at 12 months for the two arms of the study.;Secondary Objective: The secondary objectives are to estimate: • The overall response rate (ORR), as per RECIST criteria in the two treatment arms • Progression Free Survival (PFS) • Overall Survival (OS) • The safety profile of the two arms • To assess immunogenicity of intravenous aflibercept Exploratory: To Investigate •Pharmacogenetics and Biomarker testing;Primary end point(s): The primary efficacy parameter is Progression Free Survival (PFS) rate at 12 months, defined as percentage of patients alive without progression at 12 months. | — |
Countries
Germany, Italy, Spain, United Kingdom
Outcome results
None listed