Trabectedin First Line Therapy In Unfit Sarcoma Study

• Status: Completed
• Trial end date: 2016-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase II, non-randomized, two-stage study according to Bryant & Day The study enroll patients with Metastatic and locally advanced soft tissue sarcoma unfit to receive standard chemotherapy (doxorubicin/epirubicin and/or ifosfamide)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Italian Sarcoma Group
• Treatments: Trabectedin

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 soft tissue sarcoma

• 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 Performance Status 0-2

• Glomerular filtration rate ≥30 mL per min

• Adequate hematologic function: Hemoglobin ≥9 g/dL; Absolute neutrophil count ≥1,500/μL, and Platelet count ≥100,000/microliter

• Creatinine phosphokinase < 2.5 Upper Normal Limit

• Adequate hepatic function: total bilirubin < Upper Normal Limit, total alkaline phosphatase < 2.5 Upper Normal Limit, or if > 2.5 Upper Normal Limit consider alkaline phosphatase liver fraction or gamma-glutamyltransferase or 5' nucleotidase must be < Transminase <2.5 x Upper Normal Limit, Albumin > 20 g/L.

• Patient´s written informed consent

Exclusion criteria

• Prior exposure to Trabectedin

• Performance status ≥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, left ventricular ejection fraction <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.