Metastatic or local advanced Soft tissue sarcoma, not amenable for standard chemotherapy regimen (doxorubicine/epirubicine and/or ifosfamide). MedDRA version: 16.0 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Yondelis
Pharmaceutical Form: Powder for solution for infusion
Sponsors
Italian Sarcoma Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Adult patients (=18 years), who, in the judgment of the clinician, is deemed not suitable to receive an anthracycline and/or ifosfamide based chemotherapy; * Pathological diagnosis of STS; *Inoperable, locally advanced or metastatic tumor; *Unsuited to receive doxorubicine and ifosfamide: ie stable arrhythmia, previous myocardial infarction; age=80 years *Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 *Glomerular filtration rate (GFR) =30 mL per min *Adequate hematologic function: Hemoglobin =9 g/dL; Absolute neutrophil count (ANC) =1,500/µL, and Platelet count =100,000/µL *Creatinine phosphokinase (CPK) 2.5 ULN consider alkaline phosphatase liver fraction or GGT or 5’ nucleotidase must be 20 g/L. *Patient´s written 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 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: * Prior exposure to Trabectedin. * PS=2 * Prior treatment with anthracyclines and or ifosfamide. * History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 or more years and judged of negligible potential of relapse. * Active viral hepatitis or chronic liver diseases, which in the judgement of the primary investigator represents a clinical contraindication to the therapy. * Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 6 months before enrolment, uncontrolled arterial hypertension or arrhythmias, LVEF<40% * Active major infection. * Other serious concomitant illnesses. *Pregnant subjects or breast feeding, or planning to become pregnant within 6 months after the end of treatment All sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrollment and must agree to use highly effective contraception during treatment and for 6 months after the end of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to assess the activity of trabectedin as a first line treatment in locally advanced/metastatic STS patients unfit to receive standard chemotherapy ;Secondary Objective: The secondary endpoints are: Tolerability and intolerable adverse reaction rate. Intolerable toxicity is defined as every AEs leading to treatment discontinuation or dose-reduction; furthermore, any AEs of at least grade 3 not resolved within 3 weeks of appropriate management should be regarded as an intolerable toxicity event. For haematological toxicity, given that the use of growth factors will be allowed, an intolerable toxicity is defined either as any grade 4 event, or a grade 3 event not resolved with adequate treatment. AEs will be graded according to NCI-CTCAE criteria v4.0 at the first cycle of therapy. - Objective response rate (ORR) - Progression free survival (PFS) - Overall survival (OS). ;Primary end point(s): The primary end point of this trial is the Progression Free Survival Rate at 3 months (PFS3). Non progression is defined as CR, PR or SD according to RECIST v.1.1 criteria.;Timepoint(s) of evaluation of this end point: 3 months from the start therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tolerability and intolerable adverse reaction rate. Intolerable toxicity is defined as every AEs leading to treatment discontinuation or dose-reduction; furthermore, any AEs of at least grade 3 not resolved within 3 weeks of appropriate management should be regarded as an intolerable toxicity event. For haematological toxicity, given that the use of growth factors will be allowed, an intolerable toxicity is defined either as any grade 4 event, or a grade 3 event not resolved with adequate treatment. AEs will be graded according to NCI-CTCAE criteria v4.0 at the first cycle of therapy. - Objective response rate (ORR) - Progression free survival (PFS) - Overall survival (OS).;Timepoint(s) of evaluation of this end point: For Tolerability and intolerable adverse reaction rate: during all the study For Objective Response Rate (ORR): form study entry up to the end For Progression-free survival (PFS): after 6/7 weeks from the start of therapy and then every 9 weeks For Overall survival (OS): from studt entry up to death | — |
Countries
Italy
Contacts
Public ContactPiero Picci
Italian Sarcoma Group
Outcome results
None listed