Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS) (MITO 26)

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase

Completed

Phase 2

Conditions

Carcinosarcoma, Ovarian

Carcinosarcomas Uterine

Treatments

Drug: Trabectedin

Study type

Interventional

Funder types

Other

Identifiers

NCT02993705

1561

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

Female

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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