ACTRN12611000643976终止1 期
Patients with inoperable or metastatic pancreatic cancer treated with gemcitabine and temsirolimus combination to determine safety and efficacy of the combination.
Hellenic Cooperative Oncology Group0 个研究点目标入组 85 人开始时间: 2011年6月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 85
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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Provision of written informed consent
- •2. Age 18 years or older
- •3.Histologic proof of pancreatic cancer
- •4.Performance status between 50% and 100% on the Karnofsky scale
- •5.Life expectancy of greater than 12 weeks
- •6.Prior radiotherapy is allowed except for evaluable sites
- •7.Measurable or evaluable disease as according to Response Evaluation Criteria in Solid Tumors (RECIST)
- •8.All females of childbearing potential must have a negative serum or urine pregnancy test obtained within 2 days prior to initiation of treatment
- •9.White Blood Count >4000/microliter (mcl), platelets > 100,000/mcl and a hemoglobin level > 9.5 grams per deciliter (g/dl). Adequate baseline hepatic function, defined as a total bilirubin level < 2 miligrams per deciliter (mg/dl), serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) < 3 times the upper limits of normal, unless the liver is involved, in which case the transaminase levels could be up to five times the upper limits of normal. Creatinine < 1.5 mg/dl or creatinine clearance > 60 milliliter per minute (ml/min).
- •10Provision of adequate paraffin-embedded tumor tissue for translational studies and 10 milliliter (ml) peripheral blood for Deoxyribonucleic acid (DNA) study.
排除标准
- •1.Patients with ampullary, periampullary, bile duct cancers or endocrine tumors of the pancreas
- •2.History of atrial or ventricular arrhythmias and/or history of congestive heart failure, even if medically controlled. History of clinical and electrocardiographically documented myocardial infarction within the last 6 months from study entry
- •3.Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
- •4.Pre-existing motor or sensory neurotoxicity grade 2 according to the World Health Organization (WHO) criteria (intolerable paresthesia and/or marked motor loss or worse)
- •5.History of previous chemotherapy
- •6.Symptomatic brain metastases
- •7.Known, severe hypersensitivity to temsirolimus or any of the excipients of this product
- •8.Other coexisting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •9.Any unresolved chronic toxicity greater than Common Terminology Criteria (CTC) grade 2 from previous anticancer therapy
- •10. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- •11.Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater or equal than 3 times the Upper Limit of the Reference Range (ULRR) if no demonstrable liver metastases or greater than 5 times the ULRR in the presence of liver metastases
- •12.Active infection or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial/ receive protocol treatment
- •13.Pregnancy or breast feeding
- •14.Concomitant use of Cytochrome P450, family 3, subfamily A (Cyp3 A) inducers (phenytoin, carbamazepine, rifampicin, barbiturates or St John’s Wort) should be avoided and as should treatment wih strong CyP 3A inhibitors
- •15.Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment
- •16.Hypersensitivity to gemcitabine
研究者
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