EUCTR2013-003150-25-IT进行中（未招募）1 期
Phase II Trial of Temozolomide in Patients affected by Relapsed Sensitive or Refractory Small Cell Lung Cancer with MGMT methylation. GOPAV03 - TeReS
IRCCS ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI0 个研究点目标入组 19 人开始时间: 2014年11月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 19
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
入选标准
- •1. Histologically or cytologically confirmed SCLC with MGMT methylation.
- •2.Patient previously treated by one or two chemotherapy lines.
- •3.Age = 75 and Eastern Cooperative Oncology Group (ECOG) Performance Status =2.
- •4.Patients must have measurable disease, defined as at least one lesion than can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20mm with conventional techniques or as >10mm with spiral CT scan.
- •5.Patient with controlled brain metastases are eligible.
- •6.Patient previously treated with chest and/or brain RT are eligible.
- •7.Life expectancy >3 months.
- •8.Patient must have normal organ and marrow function as defined below:
- •- leukocytes >3,000/µL
- •- absolute neutrophil count >1,000/µL
- •- platelets >100,000/µL
- •- total bilirubin within normal institutional limits
- •- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- •- creatinine within normal institutional limits
- •9.Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter.
- •10.Ability to understand and the willingness to sign a written informed consent document.
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1.Histologically or cytologically confirmed SCLC without MGMT methylation.
- •2.Patients who have received three or more previous chemotherapy lines for small cell lung cancer or radiotherapy on target lesions.
- •3.Symptomatic uncontrolled CNS metastasis.
- •4.Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- •5.Presence of infection.
- •6.History or evidence of malabsorption syndrome or disease that may significantly affect gastrointestinal function.
- •7.History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or other agents used in the study.
- •8.Presence of medical problems of sufficient severity to prevent full compliance with the study.
- •9. Other known malignant neoplastic diseases in the patient’s medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix).
研究者
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