Leiomiosarcomi uterini metastatici o in progressione locale MedDRA version: 9.1 Level: LLT Classification code 10046799
Conditions
Interventions
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Trabectedin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: .05-
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 = 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Italy
Outcome results
None listed