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

Introduction: 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/m2 followed by infusion of docetaxel on days 1, 8 and 15 at doses from 20 to 30 mg/m2. 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.