Phase II trial on trabectedin in the treatment of advanced uterine and ovarian carcinosarcoma (Cs) – MITO 26 - MITO 26

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 43 人开始时间: 2020年12月15日最近更新: 2024年3月12日

试验速览

暂无简介。

•-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)
•-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

•-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

发起方

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE