ACTRN12611000207910尚未招募1 期
ETTLE Study: NeuroEndocrine Tumour Therapy with Lutetium-177 octreotate and Everolimus. A Phase I/II study of Everolimus in combination with Lutetium-177 octreotate for the treatment of advanced gastroenteropancreatic neuroendocrine tumours (GEP-NETs)
Fremantle Hospital0 个研究点目标入组 30 人开始时间: 2011年2月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 90 Years（—）
- 性别
- All
入选标准
- •1Presence of advanced, unresectable GEP-NET, which have progressed on standard therapy, or those with uncontrolled symptoms, or massive disease requiring urgent treatment. Tumour has been biopsy - proven and avid on 68Ga-octreotate PET CT or on tracer 177Lu-octreotate or 111In-octreotide gamma scanning
- •2Age > 18 years
- •3WHO performance status < 2
- •4Neutrophils >1.5 x 109/L, platelets > 100 x 109/L, Hb > 90 g/L
- •5Bilirubin < 1.5 x ULN, ALT/AST < 2.5 x ULN ( < 5 x ULN in patients with liver metastases)
- •6Fasting serum cholesterol < 7.75 mmol/L AND triglycerides < 2.5 x ULN
- •7INR < 1.5 (Anticoagulation is allowed if target INR < 1.5 on a stable dose of warfarin or on a stable dose of LMW heparin for > 2 weeks at time of enrolment
- •8Serum creatinine < 1.5 x ULN
- •9Signed informed consent
- •10Accessible for follow-up
排除标准
- •1Patients who have received anti-cancer therapies within 4 weeks of start of study drug
- •(including chemotherapy, radiation, antibody based therapy, etc)
- •2Patients who had major surgery or significant traumatic injury within 4 weeks of start of study drug, or may require major surgery during the course of the study
- •3Prior treatment with an investigational drug within preceding 4 weeks
- •4Patients receiving chronic systemic corticosteroids or another immunosuppressive agent.
- •Topical or inhaled corticosteroids allowed.
- •5Patients should not receive immunization with attenuated live vaccines within 1 week of study entry or during study period and should not be in close contact with people who have received attenuated live vaccines. Live vaccines include intranasal influenza, MMR, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines.
- •6Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
- •7Other malignancies within the past 3 years except for neuroendocrine tumour or adequately treated cancer of the cervix or basal/squamous cell carcinomata of the skin.
- •8Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as: NYHA Class 111 or IV, unstable angina, symptomatic congestive cardiac failure, myocardial infarction within 6 months of start of study, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.
- •9Severely impaired lung function defined by spirometry and DLCO that is 50% of normal predicted value and/or O2 sat that is < 88% at rest on room air
- •10Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN
- •11Active liver infections or disease such as cirrhosis, or severe hepatic impairment (Child-Pugh class C)
- •12HBV, HCV or HIV positive
- •13Impairment of gastrointestinal function or GI disease that may significantly alter the absorption of everolimus (e.g ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or substantial small bowel resection)
- •14Patients with an active bleeding diathesis
- •15Female patients who are pregnant/breastfeeding
- •16Adults of reproductive potential and their partners who are not using effective birth control methods.
- •Adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes.
- •17Women of childbearing potential must have negative urine/serum pregnancy test within 7 days prior to administration of everolimus)
- •18Patients who received prior treatment with an mTOR inhibitor (e.g sirolimus, temsirolimus,everolimus)
- •19Patients with a know hypersensitivity to everolimus or other rapamycins (e.g sirolimus, temsirolimus) or to its excipients
- •20History of non- compliance to medical regimens
- •21Patients unwilling, or unable to comply with the protocol
- •22Previous radiopeptide therapy within the last 6 months.
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