A PHASE II RANDOMIZED NON COMPARATIVE STUDY ON THE ACTIVITY OF TRABECTEDIN OR GEMCITABINE + DOCETAXEL IN METASTATIC OR LOCALLY RELAPSED UTERINE LEIOMYOSARCOMA PRETREATED WITH CONVENTIONAL CHEMOTHERAPY - TRABECTEDINE
- Conditions
- eiomiosarcomi uterini metastatici o in progressione localeMedDRA version: 9.1Level: LLTClassification code 10046799
- Registration Number
- EUCTR2009-016017-24-IT
- Lead Sponsor
- IST. DI RICERCHE FARMACOLOG. M. NEGRI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
1)Histologically proven uterine leiomyosarcoma. 2)Persistent or locally relapsed and/or metastatic disease. 3)At least one previous systemic treatment with an anthracycline ? ifosfamide or gemcitabine ? docetaxel. 4)Measurable disease, as defined by RECIST criteria. 5)ECOG PS <=2. 6)Age >= 18 years. 7)A minimum of 3 weeks since prior tumor directed therapy 8)Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower. 9)Adequate haematological function. 10)Adequate renal function. 11)Adequate liver function. 12)Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1)Prior exposure to T. 2)Peripheral neuropathy, Grade 2 or higher. 3)History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse. 4)Known CNS metastases. 5)Active viral hepatitis or chronic liver disease. 6)Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias. 7)Active major infection. 8)Other serious concomitant illnesses.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective will be to assess the clinical benefit rate (defined as 6-month progression free rate) with T in patients with locally relapsed/metastatic uterine leiomyosarcoma pretreated with anthracycline ? ifosfamide and/or gemcitabine ? docetaxel. For the subgroup population pretreated only with anthracycline ? ifosfamide the patients enrolled in the arm B will serve as a parallel internal control.;Secondary Objective: Secondary objectives will be to assess the response rate, the progression free survival, the overall survival, and the toxicity profile.;Primary end point(s): clinical benefit rate (defined as 6-month progression free rate)
- Secondary Outcome Measures
Name Time Method