Clinical Trial: Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)_MITO 26
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Phase II Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)_MITO 26
Brief Summary: Multicenter phase II study on trabectedin in patients advanced uterine and ovarian carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable toxicity. Disease response evaluation will be assessed every 9 weeks.
Detailed Summary:
This is a Phase II, multi-centre, single arm study aiming at evaluating efficacy and toxicity of Trabectedin in a population of advanced or recurrent ovarian and uterine carcinosarcoma.
Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Current Primary Outcome: Objective response rate (ORR) [ Time Frame: three years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration of response [ Time Frame: three years ]
- Progression Free Survival (PFS) [ Time Frame: three years ]the diagnosis of progression will be assessed by radiological criteria; CA 125 increases alone (GCIG criteria of progression) will not be considered as progression of disease without a radiological confirmation of progression
- Overall Survival (OS) [ Time Frame: three years ]
- Adverse events [ Time Frame: three years ]Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) v 4.03.
Original Secondary Outcome: Same as current
Information By: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Dates:
Date Received: December 1, 2016
Date Started: January 2017
Date Completion: January 2020
Last Updated: December 12, 2016
Last Verified: December 2016