title: A Prospective Phase I/II Study: Combination Chemotherapy with Docetaxel and Pemetrexed as Second-Line Treatment in Patients with Stage IIIB/IV Non-Small Cell Lung Cancer.
abstract: BACKGROUND
  Two standard single-agent chemotherapy treatments (docetaxel and pemetrexed) were combined in this trial and administered as second-line treatment in patients with non-small cell lung cancer (NSCLC). The aim of this study was to evaluate the safety and feasibility of combining docetaxel with pemetrexed.
  
  
  METHODS
  Six patients were enrolled between August 2007 and March 2009 with stage IIIB/IV NSCLC. The dose-escalation model included a pemetrexed infusion on day 1 of 200-300 mg/m(2) followed by infusion of docetaxel on days 1, 8 and 15 at doses from 20 to 30 mg/m(2). Primary study endpoints included efficacy and safety variables, also progression-free, overall and 1-year survival and time to progression.
  
  
  RESULTS
  The study was abandoned due to adverse effects defined in the protocol. The major toxicities were all of grade 3 and included fatigue, stomatitis/mucositis, diarrhea and in one case, an episode of febrile neutropenia. Two patients died during the study, but not as a direct result of the treatment.
  
  
  CONCLUSIONS
  We recommend that docetaxel or pemetrexed monotherapies should continue to be considered the standard second-line chemotherapy treatment against NSCLC. The results of this study warrant no further investigation into this particular combination treatment due to the severe toxicity effects encountered.
authors.affiliation: Department of Internal Medicine II/Krankenhaus Martha-Maria Halle-Doelau, Halle (Saale), Germany.
authors.forename: Vinzenz
authors.initials: V
authors.lastname: Kroeber
authors.affiliation: Department of Internal Medicine II/Krankenhaus Martha-Maria Halle-Doelau, Halle (Saale), Germany.
authors.forename: Sylke
authors.initials: S
authors.lastname: Nagel
authors.affiliation: Department of Internal Medicine II/Krankenhaus Martha-Maria Halle-Doelau, Halle (Saale), Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schuette
authors.affiliation: Department of Internal Medicine II/Krankenhaus Martha-Maria Halle-Doelau, Halle (Saale), Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Blankenburg
keywords: Combination chemotherapy; Docetaxel; Non-small cell lung cancer; Pemetrexed; Second-line chemotherapy