Advanced retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma MedDRA version: 16.0 Level: PT Classification code 10024627 Term: Liposarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.0 Level: PT Classification code 10073135 Term: Dedifferentiated liposarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.0 Level: PT Cl
Conditions
Interventions
Trade Name: Yondelis 1 mg
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: TRABECTEDIN
CAS Number: 114899-77-3
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Italian Sarcoma Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Persistent or locally relapsed and/or metastatic disease (in case of local disease, surgery may be technically feasible or not, but the clinical judgment must be that medical therapy is indicated) - Pathology specimens available for centralized review - Age = 18 years - ECOG PS = 2 - One or more previous systemic treatments employing anthracyclines and ifosfamide (unless one or both are clinically contraindicated) - Measurable disease, as defined by RECIST criteria - A minimum of 3 weeks since any previous medical therapy - Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower - Adequate haematological, renal and liver functions - Ability and willingness to provide 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: - Pregnant or breast-feeding women - Prior exposure to trabectedin - Peripheral neuropathy, Grade 2 or higher - History of other malignancies (except for basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 years or more and judged of negligible potential of relapse - Known central nervous system (CNS) metastases - Active viral hepatitis or chronic liver disease - Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias - Active major infection - Other serious concomitant illnesses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Confirming the activity of the drug trabectedin as second/further line treatment in retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma expressed in terms of slowing down tumour growth. ;Secondary Objective: To investigate the peculiar benefit provided by trabectedin in typical retroperitoneal sarcomas, in order to help multidisciplinary clinical decision-making;Primary end point(s): Proportion of responders to trabectedin by means of Growth Modulation Rate, that is the ratio between PFS under trabectedin (PFS) and time to progression after previous chemotherapy treatment (TTP1). The primary end point will be calculated in the overall sample;Timepoint(s) of evaluation of this end point: 6 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 6 years;Secondary end point(s): - Objective response (OR) in the overall sample - Pathological tumour response in the two eligible histological types, in patients undergoing surgery after treatment - PFS and OR in the two eligible histological types - PFS in patients who undergo surgery after, or during, trabectedin treatment and those who do not - Safety profile - Efficacy of trabectedin in reducing cancer related pain | — |
Countries
Italy
Contacts
Public ContactLaboratory of Clinical Research
IRCCS Istituto di Ricerche Farmacologiche "Mario Negri"
Outcome results
None listed