title: Phase II clinical trials on investigational drugs for the treatment of pancreatic cancers.
abstract: BACKGROUND
  Despite some recent advances in treatment options, pancreatic cancer remains a devastating disease with poor outcomes. In a trend contrary to most malignancies, both incidence and mortality continue to rise due to pancreatic cancer. The majority of patients present with advanced disease and there are no treatment options for this stage that have demonstrated a median survival > 1 year. As the penultimate step prior to Phase III studies involving hundreds of patients, Phase II clinical trials provide an early opportunity to evaluate the efficacy of new treatments that are desperately needed for this disease.
  
  
  METHODS
  This review covers the results of published Phase II clinical trials in advanced pancreatic adenocarcinoma published within the past 5 years. The treatment results are framed in the context of the current standards of care and the historic challenge of predicting Phase III success from Phase II trial results.
  
  
  CONCLUSIONS
  Promising therapies remain elusive in pancreatic cancer based on recent Phase II clinical trial results. Optimization and standardization of clinical trial design in the Phase II setting, with consistent incorporation of biomarkers, is needed to more accurately identify promising therapies that warrant Phase III evaluation.
authors: UC Davis Cancer Center, Division of Hematology and Oncology , Sacramento, CA 95817 , USA.
authors: Edward J
authors: EJ
authors: Kim
authors: Thomas J
authors: TJ
authors: Semrad
authors: Richard J
authors: RJ
authors: Bold
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000378:metabolism; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D015195:Drug Design; D015507:Drugs, Investigational / Q000627:therapeutic use*; D006801:Humans; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D015507:Drugs, Investigational
keywords: Phase II; gemcitabine; pancreatic cancer; targeted therapy