NCT01139138已完成1 期
A Phase IB/II Study of Second Line Therapy With Panitumumab, Irinotecan and Everolimus (PIE) in Metastatic Colorectal Cancer With KRAS WT
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Dose limiting toxicities
研究概览
简要总结
This study will assess the safety of panitumumab, irinotecan and everolimus when given in combination to treat advanced colorectal cancer
详细描述
This is an open label uncontrolled phase IB/II study to determine the maximum tolerated dose (MTD) and assess the efficacy of everolimus, irinotecan and panitumumab when given in combination for patients with metastatic colorectal cancer and KRAS wild-type (WT). Patients with metastatic colorectal cancer (mCRC) that have failed fluorouracil based first line therapy will be included. It is anticipated that approximately 50 patients will be enrolled over a period of 24 months
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
- •Age > 18 years
- •Histological diagnosis of colorectal cancer that is KRAS wild type
- •Metastatic disease not amenable to resection
- •Measurable disease as assessed by CT scan using RECIST criteria
- •Received and failed fluoropyrimidine therapy
- •Radiographically documented disease progression per RECIST criteria
- •For phase 1b group only, ECOG PS 0-1
- •For phase 2 group only, ECOG PS 0-2
- •Adequate bone marrow function with haemoglobin > 100 g/L, platelets > 100 X 109/l; neutrophils > 1.5 X 109/l within 7 days of enrolment
- •Adequate renal function, with calculated creatinine clearance >40 ml/min (Cockcroft and Gault) within 7 days of enrolment
- •Adequate hepatic function with serum total bilirubin < 1.25 X upper limit of normal range and ALT or AST<2.5xULN (<5xULN if liver metastases present) within 7 days of enrolment
- •Magnesium ≥ lower limit of normal within 7 days of enrolment.
- •Fasting serum cholesterol ≤ 7.75mmol/L AND fasting triglycerides ≤ 2.5 x ULN. Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
- •Life expectancy of at least 12 weeks
- •Negative pregnancy test ≤ 72 hours before commencing study treatment (women of childbearing potential only).
- •Written informed consent including consent for biomarker studies
排除标准
- •Presence of KRAS mutation in tumour sample
- •For Phase 1b group only, patients with prior pelvic radiotherapy.
- •Systemic chemotherapy, immunotherapy, approved proteins/antibodies or any investigational agent within 4 weeks prior to commencing study treatment
- •Radiotherapy within 14 days of commencing study treatment.
- •Unresolved toxicities from prior systemic therapy or radiotherapy
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol
- •Prior treatment with drugs targeting EGFR such as cetuximab, panitumumab or erlotinib
- •Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus)
- •Prior therapy with irinotecan
- •CYP3A4 enzyme inducing anti-convulsant medication ≤ 14 days prior to study treatment.
- •Ketoconazole ≤ 7 days before study treatment.
- •Uncontrolled diabetes mellitus defined by fasting glucose >1.5 x ULN.
- •Known cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
- •Patients with known interstitial lung disease or severely impaired lung function
- •Patients with active bleeding diatheses.
- •Any uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris
- •Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea
- •Chronic treatment with immunosuppressives
- •Patients with a known history of HIV seropositivity
- •Patients who have any severe and/or uncontrolled medical conditions or infections
- •Untreated or symptomatic CNS metastases
- •Patients who have a history of another primary malignant disease
- •Pregnancy or lactation.
- •Women and partners of women of childbearing potential who are not using effective contraception.
研究组 & 干预措施
Panitumumab + Irinotecan + Everolimus
Experimental
干预措施: Panitumumab (Drug)
Panitumumab + Irinotecan + Everolimus
Experimental
干预措施: Irinotecan (Drug)
Panitumumab + Irinotecan + Everolimus
Experimental
干预措施: Everolimus (Drug)
结局指标
主要结局
Dose limiting toxicities
时间窗: at end of cycle 2 (each cycle is 14 days)
To determine the maximum tolerated dose (MTD)of everolimus, irinotecan and panitumumab when given in combination for patients with Kras WT mCRC
次要结局
- Safety & toxicity(Approximately 24 weeks)
- Response rate(Assessed every 6 weeks until disease progression)
- Overall Survival(Assessed 3 monthly until death)
- Progression free survival(Until disease progression, occurrence of new disease or death)
研究者
Amanda Townsend
Dr
The Queen Elizabeth Hospital
研究点 (1)
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