Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
Uterine leiomyosarcomas and soft tissues are rare tumors with a poor prognosis when
metastatic or locally advanced. They have an average chemosensitivity mainly to doxorubicin,
ifosfamide, cisplatin, gemcitabine and trabectedin but response rates in combination in first
line does not exceed 55% for uterine leiomyosarcomas and 35% for leiomyosarcomas of soft
tissue.
The trabectedin is a new cancer drug that has obtained marketing authorization after failure
of anthracyclines and ifosfamide in the treatment of soft tissue sarcomas (STM) in Europe. It
has especially shown efficacy in myxoid liposarcomas, leiomyosarcomas and synoviosarcoma.
This study aims to evaluate the usefulness of the combination of trabectedin with doxorubicin
in first-line treatment of uterine or soft tissue leiomyosarcoma.