NCT00165854已完成2 期
Study of E7070 Combined With Capecitabine to Determine Efficacy and Recommended Dose of Combination in Patients With Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- To determine the recommended dose of E7070 in combination with capecitabine by dose adjustment;
研究概览
简要总结
Part 1: The primary purpose is to determine the recommended dose of E7070 in combination with capecitabine by dose adjustment. Part 2: The primary purpose is to determine the safety and efficacy of the combination in patients with metastatic CRC resistant to 5-fluorouracil and irinotecan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Part 1 Inclusion Criteria:
- •Histologically or cytologically confirmed solid tumour refractory to standard therapy or for whom no established therapy exists
- •Age >= 18 years
- •Karnofsky performance status of >= 70%
- •Life expectancy of >= 3 months
- •Absolute neutrophil count of >= 1.5 × 109/l, platelet count of ³ 100 × 109/l, haemoglobin level of ³ 10 g/dl (>= 6.2 mmol/l) (prior transfusion is permitted)
- •Normal hepatic and renal function as defined by serum bilirubin £ 1.5 times the upper limit of normal, ALT and AST £ 2.5 times the upper limit of normal (£ 5 times the upper limit of normal in the presence of hepatic metastases), creatinine clearance ³ 50 ml/min (by Cockroft-Gault formula)
- •Male and female patients
- •Written informed consent to participate in the study
排除标准
- •More than two previous courses of documented myelosuppresive chemotherapy (epidermal growth factor targeted therapy does not constitute a course of chemotherapy)
- •CNS metastases (a CT or MRI scan should be done if there is a clinical suspicion of CNS metastases)
- •Major surgery, chemotherapy or radiation therapy (except palliative) within 4 weeks of treatment start
- •Previous investigational cytotoxic treatment for malignant disease within 30 days before the start of the study
- •Any treatment with non-oncological investigational drugs within 30 days before the start of the study
- •Pregnancy or breast feeding (all women of childbearing potential must have a pregnancy test before inclusion in the study; post-menopausal women must be amenorrhoeic for at least 12 months). Female patients must use adequate contraceptive protection.
- •Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection
- •Uncontrolled infections
- •Clinically significant cardiac impairment or unstable ischaemic heart disease including a myocardial infarction within three months of study entry
- •History of alcoholism, drug addiction, or any psychiatric or psychological condition which in the opinion of the investigator would impair study compliance
- •History of hypersensitivity to sulphonamides
- •Prior severe or unexpected reaction to fluoropyrimidine therapy (which may be explained by dihydropyrimidine dehydrogenase deficiency or hypersensitivity to 5-FU)
- •Malabsorption syndrome or other condition which may affect absorption of drug
- •Concurrent or previous malignancy of a different tumour type within five years of starting the study except for adequately treated non-melanoma skin cancer or cervical intraepithelial neoplasia
- •Treatment within two weeks before the start of the study with any of the following: coumarin anti-coagulants, terfenadine, cisapride, cyclosporin, tacrolimus, theophylline, diazepam, sulphonylurea hypoglycaemics, phenytoin, or carbamazepine
- •Legal incapacity
- •Part 2 Inclusion Criteria:
- •Ambulant patients with progressive metastatic CRC who have received prior treatment with 5 FU and irinotecan and/or oxaliplatin either as single agents or in combination. Either 5 FU and/or irinotecan and/or oxaliplatin may have been administered in the adjuvant setting or for the treatment of metastatic disease. Patients who have received both 5-FU and irinotecan or oxaliplatin in the adjuvant setting only must have experienced disease recurrence within one year of starting chemotherapy.
- •At least one unidimensionally measurable lesion according to the RECIST criteria
- •Age ³ 18 years
- •Karnofsky performance status of ³ 70%
- •Life expectancy of ³ 3 months
- •Absolute neutrophil count of ³ 1.5 × 109/l, platelet count of ³ 100 × 109/l, haemoglobin level of ³ 10 g/dl (³ 6.2 mmol/l) (prior transfusion is permitted)
- •Normal hepatic and renal function as defined by serum bilirubin £ 1.5 times the upper limit of normal, ALT and AST £ 2.5 times the upper limit of normal (£ 5 times the upper limit of normal in the presence of hepatic metastases), creatinine clearance ³ 50 ml/min (by Cockroft-Gault formula)
- •Male and female patients
- •Written informed consent to participate in the study
- •Part 2 Exclusion Criteria:
- •Prior chemotherapy other than 5-FU, irinotecan and/or oxaliplatin
- •CNS metastases (a CT or MRI scan should be done if there is a clinical suspicion of CNS metastases)
- •Major surgery, chemotherapy or radiation therapy (except palliative) within 4 weeks of treatment start
- •Previous investigational cytotoxic treatment for malignant disease within 30 days before the start of the study
- •Any treatment with non-oncological investigational drugs within 30 days before the start of the study
- •Pregnancy or breast feeding (all women of childbearing potential must have a negative pregnancy test before inclusion in the study; post-menopausal women must be amenorrhoeic for at least 12 months). Female patients must use adequate contraceptive protection.
- •Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection
- •Uncontrolled infections
- •Clinically significant cardiac impairment or unstable ischaemic heart disease including a myocardial infarction within three months of study start
- •History of alcoholism, drug addiction, or any psychiatric or psychological condition which in the opinion of the investigator would impair study compliance
- •History of hypersensitivity to sulphonamides
- •Prior severe or unexpected reaction to fluoropyrimidine therapy (which may be explained by dihydropyrimidine dehydrogenase deficiency or hypersensitivity to 5-FU)
- •Malabsorption syndrome or other condition which may affect absorption of drug
- •Concurrent or previous malignancy of a different tumour type within five years of starting the study except for adequately treated non-melanoma skin cancer or cervical intraepithelial neoplasia
- •Treatment within two weeks before the start of the study with any of the following: coumarin anti-coagulants, terfenadine, cisapride, cyclosporin, tacrolimus, theophylline, diazepam, sulphonylurea hypoglycaemics, phenytoin, or carbamazepine
- •Legal incapacity
结局指标
主要结局
To determine the recommended dose of E7070 in combination with capecitabine by dose adjustment;
to determine the safety, tolerability and efficacy (in terms of response rate and progression-free survival) of the combination in patients with metastatic CRC.
次要结局
- Determine the pharmacokinetic profile of capecitabine and E7070 when administered in combination;
- measure duration of response and stable disease; to measure median and one year survival.
研究者
研究点 (4)
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