Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
L-sarcomas represent about one third of all adult soft tissue sarcomas (24 % liposarcomas and
12 % leiomyosarcomas). Approval for the induction of trabectedin into the treatment
armamentarium of advanced and/or metastatic soft tissue sarcomas after treatment failure with
anthracyclines and/or ifosfamide depended mainly on its activity in the L-sarcomas
(Garcia-Carbonero 2004, Le Cesne 2005, and Demetri 2009). Significant activity has been
described for the use of gemcitabine and especially the combination of gemcitabine and
docetaxel mainly in leiomyosarcomas and liposarcomas (Maki 2007). However, the combination of
gemcitabine and docetaxel is associated with significant toxicity. Pulmonary toxicity and
refractory peripheral oedema are the most common severe adverse events. The aim of the
present phase I study will be to examine safety data of this promising treatment combination
of gemcitabine and trabectedin in L-sarcomas.