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A Multinational, Randomized, Double-Blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer.

Primary Objective: To demonstrate improvement in overall survival (OS) with aflibercept by comparison to placebo in patients treated with gemcitabine for metastatic pancreatic cancer.

Site(s) and/or Type:  Pancreas

Stage: 

Principal Investigator:  Mitchell, Edith

Contact:  Melisa Mordenti, (215) 955-8979

 

Patient Eligibility

• Cytologically or histologically confirmed evidence of epithelial cancer (adenocarcinoma) of the exocrine pancreas.
• Metastatic disease. Patients with measurable and non-measurable disease, as per RECIST criteria (41) are eligible (Appendix C).
• No prior chemotherapy for pancreatic disease. Prior treatment with 5-fluorouracil, capecitabine or gemcitabine, in which 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).
  
  

Protocol Treatment
This is a prospective, multicenter, multinational, randomized (1:1), double-blind, placebo-controlled, parallel-group study comparing the efficacy of aflibercept in terms of overall survival versus placebo administered on top of gemcitabine in patients with metastatic pancreatic cancer (MPC).