Carcinosarcoma, Ovarian, Carcinosarcomas Uterine
Conditions
Brief summary
Multicenter phase II study on trabectedin in patients advanced uterine and ovarian carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable toxicity. Disease response evaluation will be assessed every 9 weeks.
Detailed description
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.
Interventions
DRUGTrabectedin
Chemotherapy drug
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | three years | The primary endpoint of this study is to evaluate the activity of trabectedin in terms of the objective response rate (ORR) in patients with advanced uterine and ovarian carcinosarcoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | three years | Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) v 4.03. |
| Duration of response | three years | — |
| Progression Free Survival (PFS) | three years | the diagnosis of progression will be assessed by radiological criteria; CA 125 increases alone (GCIG criteria of progression) will not be considered as progression of disease without a radiological confirmation of progression |
| Overall Survival (OS) | three years | — |
Countries
Italy
Outcome results
None listed