EUCTR2017-000987-14-IT进行中（未招募）1 期
Phase II Study: Maintenance therapy with Trabectedin after combination therapy Liposomal Doxorubicin plus Trabectedin vs Liposomal Doxorubicin plus Trabectedin in patients affected by relapsed ovarian cancer recurring between 6 and 12 months after platinum based chemotherapy. - TRAMANT-01
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer
- •- Female, Age = 18 years
- •- Indication for chemotherapy
- •- No more of 3 previous lines of chemotherapy
- •- Life expectancy of more of 3 months
- •- Presense of CVC
- •- Completion of n 6 cycles of combined therapy of Liposomal Doxorubincin plus Trabectidine
- •- Stable disease, partial response, complete response confirmed by radiological imaging, such as magnetic resonance imaging (MR1), computed tomography (CT) scan, or PET/CT scan, after n. 6 cycles of combined therapy of Liposomal Doxorubincin plus Trabectidine
- •- Relapsed ovarian cancer with a progression free interval of six and twelve (6-12) months (calculated from the first day of the last cycle of the last platinum-based chemotherapy until the date of progression confirmation through radiologic imaging). Patients may have received up to three platinum-based chemotherapy lines, of which at least one must have contained a taxane
- •- Measurable or evaluable disease confirmed by radiological imaging, such as magnetic resonance imaging (MR1), computed tomography (CT) scan, or PET/CT scan at study entry (CA -125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression) or histological proven recurrent ovarian cancer even in the absence of postoperatively measurable or evaluable lesions
- •- Eastern Cooperative Oncology Group (ECOG) performance status (PS)=2
- •- Patients must be accessible for treatment and follow-up
- •- Adequate organ Function within 14 days prior to first cycle as evidenced by:
- •A.Peripheral blood counts and serum chemistry values:
- •Hemoglobin=9 g/dl
- •Absolute neutrophil count (ANC) =1,500
- •Platelet count = 100,000
- •Estimated glomerular filtration rate = 60 ml/min according to the Cockroft-Gault formula
- •Creatine phosphokinase (CPK) = 2.5 x ULN
- •B.Hepatic function variables:
- •Total bilirubin = ULN
- •Total alkaline phosphatase = 2.5 ULN (consider hepatic isoenzymes of 5-nucleotidase or GGT if the elevation could be osseous in origin)
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be = 2.5 x ULN
- •- All randomized patients must be able to receive dexamethasone or its equivalent,
- •- Informed consent of the patient obtained within the 6th chemo-cycle and before any study-specific procedure
- •- Determination of BRCA 1 and BRCA 2 mutation within the screening visit
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)
- •- Previous or concomitant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix)
- •- ECOG Performance status =3
- •- Heart disease (congestive heart failure, myocardic infarction, atrioventricular block of any grade, severe arrhythmias)
- •- Prior exposure to trabectedin
- •- Prior resistance to anthracyclines or PLD defined as a progression: during anthracycline-based chemotherapy or a recurrence within 6 months from its ending
- •- Prior severe PLD related toxicity
- •- Prior exposure to cumulative doses of doxorubicin >400mg/m² or epirubicin >720mg/m²
- •- Treatment with any investigational product within 30 days prior to inclusion in the study
- •- Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months or > 12 months from the last dose of platinum
- •- Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases
- •- Pre-existing grade > 1 motor or sensory neuropathy according to the National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0
- •- History of liver disease
- •- Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
- •- Breastfeeding or pregnant women. Women of child bearing potential must use effective contraception during treatment and 3 months thereafter, which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to patients that are surgically sterile)
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