Phase II trial on trabectedin in the treatment of advanced uterine and ovarian carcinosarcoma (Cs)

Phase 1

• Conditions: advanced ovarian and uterine carcinosarcoma; MedDRA version: 20.0Level: LLTClassification code 10052204Term: Ovarian carcinosarcomaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10007508Term: Carcinosarcoma uterusSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005153-12-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-15
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 43

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:
a) Hematopoietic; Absolute neutrophil count = 1,500/mm^3; Platelet count = 100,000/mm^3; Hemoglobin = 9 g/dL
b) Hepatic; AST and ALT = 1.5 times upper limit of normal (ULN)* ; Alkaline phosphatase = 2.5 times ULN* ; Bilirubin = 1.5 times ULN NOTE: * = 3 times ULN if liver metastases are present
c) Renal; Creatinine Clearance = 45 mL/min or Serum Creatinine =1.5 x ULN
d) 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified