Clinical trial NCT02993705: Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)
Official title: Phase II Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinosarcoma, Ovarian
Carcinosarcomas Uterine
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: three years
Secondary outcomes:
measure: Duration of response
timeFrame: three years
measure: Progression Free Survival (PFS)
timeFrame: three years
measure: Overall Survival (OS)
timeFrame: three years
measure: Adverse events
timeFrame: three years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Domenica Lorusso, Prof.
role: PRINCIPAL_INVESTIGATOR
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