EUCTR2009-014772-22-NL进行中（未招募）不适用
Chloroquine as an anti-autophagy drug in small cell lung cancer (SCLC) patients: A phase I trial to be followed by a phase II trial. - chloroquine in SCLC
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Fase I, Step 1: chloroquine added to standard dose cisplatin-etoposide in extensive disease SCLC.
- •1. Histologically or cytologically confirmed ``extensive disease`` (Stage T0-4 N0-3 M1) small cell lung cancer
- •2. At least one measurable disease site, defined as lesion of = 1 cm unidimensionally on CT-scan.
- •3. WHO performance status 0-2
- •4. Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
- •5. Calculated creatinine clearance at least 60 ml/min
- •6. Adequate hepatic function: Total bilirubin = 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase = 2.5 x ULN for the institution (in case of liver metastases = 5 x ULN for the institution)
- •7. No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
- •8. Life expectancy more than 6 months
- •9. Willing and able to comply with the study prescriptions
- •10. 18 years or older
- •11. Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
- •12. Ability to give and having given written informed consent before patient registration
- •13. No mixed pathology, e.g. non-small cell plus small cell cancer
- •Fase I, Step 2: chloroquine added to standard dose cisplatin-etoposide plus radiotherapy in limited disease SCLC.
- •1. Histologically or cytologically confirmed `limited disease` ie stage T0-4 N0-3 M0 small cell lung cancer, excluding malignant pleural/pericardial effusion.
- •2. At least one measurable disease site, defined as lesion of = 1 cm unidimensionally on CT-scan.
- •3. WHO performance status 0-2
- •4. Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
- •5. Calculated creatinine clearance at least 60 ml/min
- •6. Adequate hepatic function: Total bilirubin = 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase = 2.5 x ULN for the institution (in case of liver metastases = 5 x ULN for the institution)
- •7. No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
- •8. Life expectancy more than 6 months
- •9. Willing and able to comply with the study prescriptions
- •10. 18 years or older
- •11. Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
- •12. Ability to give and having given written informed consent before patient registration
- •13. No mixed pathology, e.g. non-small cell plus small cell cancer
- •Fase II, step 1:
- •1. Histologically or cytologically confirmed ``extensive disease`` (Stage T0-4 N0-3 M1) small cell lung cancer
- •2. At least one measurable disease site, defined as lesion of = 1 cm unidimensionally on CT-scan
- •3. WHO performance status 0-2
- •4. Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
- •5. Calculated creatinine clearance at least 60 ml/min
- •6. Adequate hepatic function: Total bilirubin = 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase = 2.5 x ULN for the institution (in case of liver metastases = 5 x ULN for the institution)
- •7. No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
- •8. Life expectancy more than 6 months
- •9. Willing and able to comply with the study prescriptions
- •10. 18 years or older
- •11. Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
- •12. Ability to give and having given written informed consent before patient registra
排除标准
- •the opposite of the above
研究者
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