EUCTR2014-002417-36-IT进行中（未招募）1 期
An open-label, randomized, multicenter, phase II trial designed to estimate the activity of CAPTEM combination versus FOLFIRI as second line treatment in patients who have progressed on or after first-line oxaliplatin - containing chemotherapy for advanced, MGMT methylated, RAS mutated colorectal cancer - CAPTEM vs FOLFIRI
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
- 82
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
- All
入选标准
- •Signed Informed Consent Form
- •Histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum, with MGMT promoter methylation and RAS mutation.
- •Progressive disease on or after a first-line oxaliplatin-containing chemotherapy regimen for mCRC with or without bevacizumab or other anti-angiogenic drugs. Patients with documented disease relapsed within 6 months from the completion of adjuvant oxaliplatin-based chemotherapy are considered eligible.
- •Patients must have received oxaliplatin-containing chemotherapy for = 3 months. No more than one prior chemotherapy regimen for metastatic disease is allowed.
- •Disease that is measurable per RECIST v1.1
- •Age = 18 years and = 75 years
- •Life expectancy = 12 weeks
- •ECOG Performance Status of 0 or 1
- •Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 14 days prior to first administration of study treatment: ANC = 1500/µL Platelet count = 100,000/µL Hemoglobin = 9.0 g/dL Albumin = 2.5 g/dL
- •Total bilirubin = 1.5 × the upper limit of normal (ULN)
- •AST, ALT, and/or alkaline phosphatase = 2.5 × ULN, with the following exceptions: Patients with documented hepatic metastases are eligible with AST, ALT, and/or alkaline phosphatase = 5 × ULN. Patients with documented bone metastases are eligible with alkaline phosphatase = 5 × ULN.
- •Serum creatinine = 1.5 × ULN, or creatinine clearance = 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation: (140 - age) × (weight in kg) × (0.85 if female) 72 × (serum creatinine in mg/dL)
- •INR and aPTT = 1.5 × ULN
- •For female patients of childbearing potential and male patients with partners of childbearing potential, documented agreement (by patient and/or partner) to use an effective means of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of the study and for 60 days for female patients or 150 days for male patients with partners of childbearing potential after the last infusion of study treatment.
- •Consent to provide mandatory archival tumor tissue for biomarker testing
- •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 41
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 41
排除标准
- •Prior treatment with irinotecan and temozolomide
- •Major surgical procedure within 4 weeks and radiotherapy within 2 weeks prior to Day 1 Cycle 1
- •Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy. Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible.
- •Known clinically significant dihydropyrimidine dehydrogenase deficiency
- •Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders; ulcers or bone fractures), active infection requiring IV antibiotics
- •History of heart failure of any New York Heart Association criteria or serious cardiac arrhythmia requiring treatment (except for atrial fibrillation and paroxysmal supraventricular tachycardia)
- •History of myocardial infarction within 6 months prior to Cycle 1, Day 1, or history of unstable angina
- •Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; or current alcohol abuse
- •History of bleeding diathesis or coagulopathy other than that due to anticoagulation therapy
- •Patients receiving oral coumarin-derived anticoagulants
- •Active haemoptysis (defined as bright red blood of ½ teaspoon or more) within 30 days prior to Cycle 1, Day 1
- •Known HIV infection
- •Untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible provided they meet all of the following criteria:
- •Measurable disease outside the CNS as defined by RECIST v1.1.Radiotherapy completed = 4 weeks prior to Cycle, 1 Day 1
- •Pregnancy (positive pregnancy test) or lactation. Women of childbearing potential (including those who have had a tubal ligation) must have a documented negative serum pregnancy test within 14 days prior to Cycle 1, Day 1.
- •Inability to take oral medications.
- •Malignancies other than CRC within 3 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix
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