NCT03149679终止2 期
Treatment of Patients With Metastatic Colorectal Cancer Harboring TP53 Mutations With Dose-dense Cyclophosphamide - the p53 Colorectal Cancer Trial
Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年5月9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
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
Single center, open labeled, phase 2 clinical trial, where patients with metastatic colorectal cancer are selected for treatment with dose dense Cyclophosphamide every second week based on TP53 mutation status; i.e. only patients with TP53 mutated tumors may be included in the treatment arm.
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
- •Metastatic colorectal cancer patients for whom conventional therapy has failed; defined as 2 lines of chemotherapy including oxaliplatin or irinotecan- containing regimens as well as an EGFR inhibitor if applicable.
- •Tumor lesion suitable for biopsy
- •Age >18 years
- •Clinically or radiologically measurable tumor deposits according to the RECIST criteria
- •WHO performance status 0-1
- •Radiology studies (CT thorax/abdomen/pelvis) and echo cor and ECG must be performed within 28 days prior to registration.
- •Before patient registration in the trial, written informed consent must be given according to national and local regulations.
- •Blood test requirements:
- •Neutrophils > 1.0 e9/L Platelets > 75 e9/L Bilirubin < 20 µmol / L. Serum creatinine < 1.5 x ULN
排除标准
- •Co-morbidity including, but not limited to, impaired renal-, liver or bone marrow function, that based on the assessment of the treating physician, may preclude the use of cyclophosphamide at actual doses.
- •Known hypersensitivity to the study drug, its metabolites or any excipients in the infusion solution.
- •Psychological, familial, sociological or geographical condition(s) potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •Pregnant or lactating patients cannot be included.
- •Clinical evidence of serious coagulopathy. Prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist.
- •Patient not able to give an informed consent or comply with study regulations as deemed by study investigator.
研究组 & 干预措施
Cyclophosphamide arm
Experimental
Dose dense cyclophosphamide (1800 Mg/m2) administered intravenously every second week.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 4 months
Partial response (PR) or complete response (CR) as defined by the RECIST criteria
次要结局
- Possible molecular markers of therapy response/resistance and survival outcome beyond TP53 mutations will be examined.(10 years)
- Number of patients with treatment response among patients harboring TP53 mutations belonging to particular mutation subgroups(10 years)
- Clinical benefit rate (CBR)(5 years)
- Recurrence-free and overall survival, compared to historical data(All patients will be followed for 5 years or until death to record survival outcome)
- Safety and tolerability of the study treatment including recording of number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Every second week during the treatment period from start of treatment, and thereafter every second month for 5 years or until death)
研究者
研究点 (1)
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