NCT04122911已完成2 期
A Phase II Single Arm Trial Evaluating the Efficacy and Safety of Temozolomide for Second-Line Treatment of Neuroendocrine Carcinomas Progressing After First-Line Platinum- Based Therapy
National Cancer Institute, Naples1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年1月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
To assess the efficacy and safety of Temozolomide for second-line treatment of Neuroendocrine Carcinomas progressing after first-line Platinum-based therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patient's awareness and willingness to comply with the study requirements.
- •Patients ≥18 years of age.
- •Histologically confirmed Metastatic Neuroendocrine Carcinoma (Ki67>20% Ki67 must be quantified in percentage) with documented progression of disease per investigator assessment following or during first-line platinum-based treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-
- •At least 28 days since prior radiation therapy or surgery and recovery from treatment.
- •Patients must have measurable disease which must be evaluable per RECIST v1.
- •Estimated life expectancy of ≥12 weeks.
排除标准
- •- Patients < 18 years of age
- •Diagnosis of well differentiated G1/G2 NEN
- •Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would prevent the patient from meeting the study requirements.
- •Serious active infection requiring i.v. antibiotics and/or hospitalization at study entry.
- •Patients who are treated with any medicinal product that contraindicates the use of the study drug, may interfere with the planned treatment, affects patient compliance or puts the patient at high risk for treatment-related complications.
- •Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
- •Patients with meningeal carcinomatosis
- •Patients with organ allografts requiring immunosuppression
- •Patients with known positive HIV status
- •Patients with a hypersensitivity to Temozolomide or Dacarbazine
- •Any laboratory values at baseline as follows:
- •Hematology:
- •Absolute Neutrophil Count (ANC) <1.5x109/L or 1500/mm3
- •Platelet count <100x109/L
- •Hemoglobin <8 g/dL (Note: hemoglobin levels may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors).
- •Coagulation:
- •International Normalized Ratio (INR) >1.5 except for patients on stable anticoagulant therapy
- •Activated Partial Thromboplastin Time (aPTT) ≥1.5 times upper limit of normal (ULN) or greater than the lower limit of the therapeutic range Note: The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of Day 1, Cycle
- •Serum chemistry:
- •Total bilirubin >1.5 times ULN
- •Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >2 times ULN (>5 times ULN for patients with known liver involvement)
- •Alkaline Phosphatase (ALP) >2 times ULN (>5 times ULN for patients with known liver involvement and >7 times ULN for patients with known bone involvement).
研究组 & 干预措施
Temozolomide
Experimental
Temozolomide 75mg/m2 metronomic schedule: one week on/one week off in a cycle of 28 days
干预措施: Temozolomide (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: 6 months
Overall response rate (ORR)
次要结局
- Overall survival (OS)(12 months)
- Safety and tolerability - Incidence of abnormal laboratory test results(1 month)
- Safety and tolerability - Incidence of abnormal vital signs(1 month)
- Second Line Progression Free Survival (PFS)(12 months)
- Safety and tolerability - Incidence of treatment-related adverse events (AE).(1 month)
- Clinical Benefit Rate (CBR)(12 month)
- Safety and tolerability - Incidence of abnormal ECG readings(1 month)
- Quality of Life (QoL) - QoL will be assessed using the European Organization for Research and Trial in Cancer QOL core (EORTC QLQ-C30) questionnaire (version 3) [Quality of life questionnaire - QLQ](1 month)
- Quality of Life (QoL) - QoL will be assessed using disease specific modules for Neuroendocrine Tumors (NET), the EORTC QLQ GINET21 (EORTC QLQ Gastrointestinal Neuroendocrine Tumors 21).(1 month)
研究者
研究点 (1)
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