Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)

This is a Phase II, multi-centre, single arm study aiming at evaluating efficacy and toxicity of Trabectedin in a population of advanced or recurrent ovarian and uterine carcinosarcoma.

Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.

Inclusion criteria

• Histologically documented Stage I-IV or recurrent uterine or ovarian carcinosarcoma not amenable to surgery or radiotherapy
• No more than 2 previous chemotherapy lines
• PS 0-2 (ECOG)
• Age> 18
• Measurable disease
• Life expectancy of at least 3 months
• Adequate organ functions:

• Hematopoietic; Absolute neutrophil count ≥ 1,500/mm^3; Platelet count ≥ 100,000/mm^3; Hemoglobin ≥ 9 g/dL Hepatic; AST and ALT ≤ 1.5 times upper limit of normal (ULN)*; Protocol Version 1.0_05.09.2016 6 Alkaline phosphatase ≤ 2.5 times ULN*; Bilirubin ≤ 1.5 times ULN NOTE: * ≤ 3 times ULN if liver metastases are present Renal; Creatinine Clearance ≥ 45 mL/min or Serum Creatinine ≤1.5 x ULN Serum Albumin >3.0 g/dL
• Previous Brachytherapy treatment for uterine carcinosarcoma is allowed
• No other invasive malignancy within the past 3 years except non-melanoma skin cancer
• Written Informed Consent

Exclusion criteria

• More than 2 previous chemotherapy lines
• Single tumor lesion inside a previous irradiated filed
• Pregnant (potentially fertile patients must be not in pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test)
• Active infection requiring antibiotics
• Symptomatic peripheral neuropathy > grade 2 according to the NCI Common Toxicity Criteria.
• Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.
• Unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with achievement of study objectives
• Psychological or sociological conditions, addictive disorders, or family problems, which would preclude compliance with the protocol