Safety and Efficacy evaluation in soft tissue sarcoma unfit to received standard chemotherapy

• Conditions: Metastatic or local advanced Soft tissue sarcoma, not amenable for standard chemotherapy regimen (doxorubicine/epirubicine and/or ifosfamide).; MedDRA version: 16.0Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001467-23-IT
• Lead Sponsor: Italian Sarcoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-06
• Last Update Posted: 18 November 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
*Adequate hepatic function: total bilirubin < ULN, total alkaline phosphatase < 2.5 ULN, or if > 2.5 ULN consider alkaline phosphatase liver fraction or GGT or 5’ nucleotidase must be < ULN, AST and ALT <2.5 x ULN, Albumin > 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

* 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified