NCT00777478Unknown1 期
A Phase I Dose Escalation Study With Sunitinib (SutentR) in Combination With Capecitabine and Irinotecan (Capiri) in Previously Treated Patients With Advanced Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
The primary objective of this Phase 1 study is to identify the recommended dose of capiri and of sunitinib for combination therapy subsequent phase II trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histological proof of colorectal cancer
- •Patients should have failed one previous line of systemic treatment for advanced disease (and not more than one treatment line), either with fluoropyrimidine monotherapy or in combination with oxaliplatin and/or bevacizumab.
- •No prior treatment with irinotecan or sunitinib
- •Age ≥ 18 years
- •WHO PS 0-1 (see Appendix 3, corresponding with Karnofsky ≥ 70% )
- •Life expectancy ≥ 12 weeks
- •Written informed consent
排除标准
- •No measurable disease according to RECIST criteria.
- •Prior anti-cancer therapy < 3 weeks before first dose. For cetuximab < 30 days or bevacizumab < 60 days prior to the first dose.
- •Unresolved toxicity > CTC gr 1 from previous anti-cancer therapy (including radiotherapy) except for alopecia.
- •Inadequate bone marrow function (Hb ≤ 5.6 mmol/L, absolute neutrophil count (ANC) ≤ 1.5 x 109/L, platelets ≤100 x 109/L)
- •renal dysfunction (serum creatinine ≥ 1.5x ULN and glomerular filtration rate ≤ 50 ml/min)
- •Prothrombin time (PT) and activated partial thromboplastin time (APTT) > 2x ULRR
- •Hepatic dysfunction (serum bilirubin ≥ 1.5x ULN, serum transaminases ≥ 2.5 x ULN)
- •Greater than +1 proteinuria on two consecutive dipsticks taken no less then 2 weeks apart unless urinary protein < 1,5 g in a 24 Hr period.
- •Pregnant or lactating women
- •History of clinical signs/symptoms of CNS metastases
- •Previous intolerance of fluoropyrimidine therapy, known dihydropyrimidine dehydrogenase (DPD) deficiency. Known hypersensitivity to irinotecan or sunitinib of their excipients.
- •No major surgery < 4 weeks prior to study entry.
- •No radiotherapy < 4 weeks prior to study entry except for palliative radiotherapy at focal sites.
- •Any evidence of concurrent severe or uncontrolled disease (i.e. uncontrolled hypertension, congestive heart failure, myocardial infarction < 6 months, chronic active infection, poorly regulated diabetes mellitus)
- •Any previous significant cardiovascular event during previous fluoropyrimidine therapy (i.e.
- •myocardial ischemia or infarction, arterial thrombosis, pulmonary emboli)
- •Mean Qtc with Bazetts correction > 470 msec in screening ECG, or a history with familial long QT syndrome
- •Significant haemorrhage (>30 ml bleeding/episode in the last 3 months) or haemoptysis (>5 ml fresh blood in previous 4 weeks)
- •History of impairment of gastrointestinal function or -disease that may significantly impair the absorption of oral drugs (i.e. uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, bowel obstruction, or inability to swallow tablets)
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •Concomitant use medication that may significantly affect hepatic cytochrome P450 drug metabolizing activity by way of enzyme induction or inhibition < 2 weeks if the first dose and throughout the study period (see Appendix 2)
- •Other concomitant anti-cancer therapy.
结局指标
主要结局
Maximum Tolerated Dose
时间窗: after every completed doselevel
次要结局
- determine the safety and toxicity profile using the CTCAE criteria.(after every completed doselevel)
研究者
研究点 (2)
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