Patients Treated with Gemcitabine for Metastatic Pancreatic Cancer.
Conditions
Interventions
Product Name: aflibercept
Product Code: AVE0005, VEGF Trap
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: aflibercept
Current Sponsor code: AVE0005
Other descriptive n
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Cytologically or histologically confirmed evidence of epithelial cancer (adenocarcinoma) of the exocrine pancreas. - Metastatic disease. Patients with measurable and with non-measurable disease (as per RECIST criteria) are eligible. - No prior chemotherapy for pancreatic disease. Prior treatment with 5-fluorouracil, capecitabine or gemcitabine, in which the chemotherapy was used as a radio-sensitizing agent, is allowed if the treatment-free interval is of at least 3 months (time between last chemotherapy dose and randomization). 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: - Related to the methodology : • Chemotherapy or other systemic therapy for pancreatic cancer. • Less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of randomization. Less than 28 days elapsed from prior radiation therapy. • Prior treatment with anti-VEGF or VEGF-Receptor-inhibitors. • Age 5 years are allowed. • Participation in other clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. • Any of the following events within the 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, grade 3 or 4 gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event. • Any of the following events within the 6 months prior to randomization: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft surgery, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack. • Occurrence of deep vein thrombosis within 4 weeks prior to randomization. • Known human immunodeficiency virus (HIV) infection requiring antiretroviral treatment or acquired immunodeficiency-syndrome (AIDS)-related illness. • Other severe acute or chronic medical condition, which could impair the ability of the patient to participate to the study or to interfere with interpretation of study results. • Absence of signed and dated Institutional Review Board (IRB)-/Independent Ethical Committee (IEC)-approved patient informed consent form prior to enrollment into the study. • Pregnant or breast-feeding woman. Positive serum or urine pregnancy test for women of reproductive potential prior to randomization. • Patient with reproductive potential (male, female) 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. - Related to aflibercept • Urine Protein-Creatinine Ratio (UPCR) > 1 on morning spot urinalysis or proteinuria > 500 mg/24h. • Serum Creatinine > 1.5 x upper limit of normal (ULN). If creatinine 1.0 - 1.5 x ULN, creatinine clearance, calculated according to Cockcroft-Gault formula 150/100 mmHg (= grade 2 according to NCI CTCAE v. 3.0), or systolic blood pressure >180 mmHg if diastolic blood pressure 3) within the 4 weeks prior to randomization. • Evidence of clinically significant bleeding diathesis, non-healing wound or underlying coagulopathy (e.g. INR>1.5 without vitamin K antagonist therapy…). - Related to Gemcitabine • Absolute neutrophil c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate improvement in overall survival (OS) with aflibercept by comparison to placebo in patients treated with gemcitabine as first line treatment for metastatic pancreatic cancer.;Primary end point(s): Overall Survival (OS), defined as the time interval from the date of randomization to the date of death due to any cause.;Secondary Objective: - To compare in the two treatment arms (by sequential order of statistical analysis): • Progression Free Survival (PFS), • Clinical Benefit assessed by Time to symptoms worsening (TTSW) and improvement in tumor related symptoms, • Overall Response Rate (ORR) in patients with measurable disease at study entry (as per RECIST criteria). - To assess the overall safety in the two treatment arms. - To assess immunogenicity of iv aflibercept. - To perform population pharmacokinetic evaluation. | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Poland, Spain
Outcome results
None listed