EUCTR2012-002766-13-IT进行中（未招募）不适用
A phase 2 study of temozolomide in patients affected by metastatic colonrectal cancer with hypermethylation of 06-methylguanine-dna-methyltransferase
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点目标入组 41 人开始时间: 2012年9月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 41
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
- •-Pathologically confirmed colorectal adenocarcinoma and documented metastatic disease
- •-MGMT promoter hypermethylation assessed by MS-PCR. The analysis will be performed at Università Cattolica del Sacro Cuore, Molecular Pathology Lab.
- •-Disease progression during or following at least two lines of chemotherapy including fluoropyrimidines, irinotecan, oxaliplatin, anti-VEGF and (if KRAS wild-type) anti EGFR drugs, or unacceptable toxicity to these drugs.
- •-Progression free interval less than 6 months from the end of the previous treatment
- •-Male and female patients, age = 18 years
- •-Performance Status (ECOG): = 2
- •-At least one measurable lesion meeting the RECIST 1.1 criteria
- •-Written and signed informed consent obtained prior to beginning any protocol-specific procedures.
- •-Life expectancy =12 weeks
- •-Effective means of contraception (i.e. sexual abstinence) during the study and for a period of at least 6 mon ths after the last administration of the study drug.
- •-Adequate hematological function (White Blood Cell count = 3 x 109/l, Absolute neutrophil count = 1.5 x 109/l, and platelet count = 100 x 109/l)
- •-Adequate liver function (total bilirubin < 1.5 x upper limit of normal, unless the patient has documented Gilbert’s syndrome; ALT = 2.5 x upper limit of normal or = 5 x upper limit of normal in patients with liver metastases)
- •-Adequate renal function: serum creatinine = 1.5 x upper limit of normal or creatinine clearance = 50 ml/min (according to the formula of Crockcroft and Gault)
- •-INR and aPTT = 1.5 x upper limit of normal (unless on therapeutic anti-coagulation)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •-History of any other serious or uncontrolled disease that contraindicates the use of the investigational drug
- •-Pregnancy or breast feeding (female patients with childbearing potential must have a negative serum beta-HCG).
- •-Bowel obstruction
- •-Alcohol or drug abuse.
- •-Legal incapacity or limited legal capacity
- •-Existing acute reversible effects of prior treatment. This generally means at least 3 weeks should have elapsed since prior chemotherapy and at least 4 weeks since prior (radical) radiotherapy or major surgery with full recovery
- •-History of another malignancy within 5 years prior of enrollment, except for adequately treated carcinoma in situ of the cervix and non-melanoma skin cancer. Patients treated for other malignancies with curative intent and disease free at least for 5 years are elegible.
- •-Brain metastasis not well controlled. Eligible patients must be asymptomatic, can not be receiving steroids or anticancer treatment, and must be enrolled at least 1 month after the end of the radiotherapy treatment. CT or MRI scan of the brain is mandatory in case of clinical suspicion of CNS metastases.
- •-Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- •-Current known infection with HIV, HBV, or HCV
- •-Known hypersensitivity to the study drug or to one of the excipients
- •-Documented intolerance to galactose, lattase deficiency or galactose malabsorption
研究者
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