Clinical Trial: Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicentric Phase II Trial Studying Efficacy of Doxorubicin Associated With Trabectedin (Yondelis) in First Line Treatment on Patients With Metastatic Leiomyosarcoma (U
Brief 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.
Detailed Summary:
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Current Primary Outcome: Disease control rate [ Time Frame: Assessed every 6 weeks from inclusion up to 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Response rate [ Time Frame: Assessed every 6 weeks from inclusion up to 6 months ]Assessed using RECIST criteria
- Progression Free Survival [ Time Frame: Assessed every 6 weeks from inclusion up to 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Gustave Roussy, Cancer Campus, Grand Paris
Dates:
Date Received: May 5, 2014
Date Started: June 2010
Date Completion:
Last Updated: January 25, 2017
Last Verified: January 2017