Phase I Study of Temsirolimus and Cetuximab in Adults Patients With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
Cetuximab is an EGFR inhibitor that has shown efficacy alone or in combination in colorectal cancer or head and neck cancer in several phase II/III studies.
Temsirolimus is a new mTOR inhibitor that has shown interesting results in several Phase I/II studies in advance kidney cancer of bad prognosis.
Study hypothesis is that combination of those two compounds and the inhibition of two pathways at the same time will have more efficiency on tumoral growth than the inhibition of those pathways in isolation.
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
- •* Patients with malignant tumor confirmed histologically or cytologically who does not respond to usual therapeutics or for whom there is no curative treatment
- •* Age \>/= 18 years
- •* ECOG 0 or 1
- •* Life expectancy \>/= 12 weeks
- •* Grade \/= 3.0 g/dL
- •* Neutrophil counts (PNN) \>/= 1 500/mL
- •* Platelets \>/= 100 000/mL
- •* Hemoglobin \>/= 9.0 g/dL
- •* Creatinin \
排除标准
- •Treatment by chemotherapy, radiotherapy, surgery or the two compounds of the study within 4 weeks before the inclusion
- •Previous treatment with an association of mTOR inhibitor or EGFR inhibitor
- •Diagnosis of a secondary cancer within the last 3 years except for a basal-cell carcinoma, cutaneous spinocellular cancer or in situ carcinoma well treated
- •Grade >/= 2 nephropathy according to NCI CTCAE
- •Current treatment with curative dose of coumadin or heparin of low molecular weight
- •Previous uncontrolled brain metastases, medullar compression or carcinomatosis meningitis or any proof of leptomeningeal pathology or metastasis.
- •Presence of one og those pathologies during the last 12 months before the inclusion:
- •myocardial infarction
- •angina pectoris
- •bypass of coronal or peripheral arteries
- •heart failure
- •cerebral bleeding
- •pulmonary embolism
- •Grade 3 bleeding according to NCI CTCAE criteria less than 3 weeks before treatment start
- •Uncontrolled high blood pressure (>150/100mhHg)
- •Grade >/=2 heart rate disorder, atrial fibrillation whichever the grade, lengthen of QTC >450 msec for male or >470 msec for female.
- •Patients HIV positive
- •Pregnant or breastfeeding woman
- •Patients with psychiatric disorder
- •Active alcoholism
- •Previous pulmonary interstitial disease
- •Previous hypersensitivity to antihistamine treatment and/or medical contraindication for an antihistamine or corticoid treatment
研究组 & 干预措施
Cetuximab + Temsirolimus
Cetuximab: 400mg/m² IV for 120 minutes Temsirolimus: 15mg IV for 60 minutes
干预措施: Temsirolimus (Drug)
Cetuximab + Temsirolimus
Cetuximab: 400mg/m² IV for 120 minutes Temsirolimus: 15mg IV for 60 minutes
干预措施: Cetuximab (Drug)
结局指标
主要结局
Safety
时间窗: Assessed every every week from inclusion during the four first weeks then at week 8 then every 2 months until death or progression whichever comes first up to 24 months
Adverse effects will be assessed using NCI-CTC.AE v.4
次要结局
- Efficacy(Assessed every 2 cycles (44 days) from inclusion up to 24 months)