EUCTR2008-002791-10-GR进行中（未招募）不适用
GEMCITABINE COMBINED WITH THE mTOR INHIBITOR TEMSIROLIMUS (CCI-779) IN PATIENTS WITH INOPERABLE OR METASTATIC PANCREATIC CANCER
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 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 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.WBC>4000/µl, platelets > 100,000/µl and a hemoglobin level > 9.5 g/dl. Adequate baseline hepatic function, defined as a total bilirubin level < 2 mg/dl, SGPT and 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 ml/min.
- •10Provision of adequate paraffin-embedded tumor tissue for translational studies and 10 ml peripheral blood for DNA study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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 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 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 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 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
相似试验
进行中（未招募）
1 期
Afatinib as Cancer therapy for Exocrine Pancreatic Tumourshistologically confirmed diagnosis of metastatic pancreatic adenocarcinomaMedDRA version: 19.0Level: LLTClassification code 10033575Term: Pancreas cancerSystem Organ Class: 100000004864EUCTR2011-004063-77-DEKlinikum der Universität München, Anstalt des öffentlichen Rechts119
进行中（未招募）
不适用
A PHASE II STUDY OF THE COMBINATION OF GEMCITABINE AND IMATINIB MESYLATE IN PRETREATED PATIENTS WITH MALIGNANT PLEURAL MESOTHELIOMAMalignant Pleural MesotheliomaEUCTR2014-002876-10-ITIstituto Clinico Humanitas
进行中（未招募）
1 期
GEMCITABINE-OXALIPLATINE PLUS RITUXIMAB (R-GEMOX) IN REFRACTORY/RELAPSED PATIENTS WITH CD20 POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA, NON ELIGIBLE FOR HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOTRANSPLANTATION - R-GEMOXRefractory/relapsed patients with CD 20 positive large B-cell lymphomaEUCTR2005-002344-26-BEGELA
招募中
Unknown
Gentamicin intratympanic injection concurrent with dexamethasone in refractory Meniere’s disease.KCT0008375Yonsei University Health System, Severance Hospital50
进行中（未招募）
不适用
PHASE II TRIAL OF THE COMBINATION OF GEMCITABINE AND OXALIPLATIN IN THE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARCINOMA OF UNKNOWN PRIMARY SITEEstudio fase II de la combinación de gemcitabina y oxaliplatino en el tratamiento de pacientes con adenocarcinoma matastático de origen desconocido.EUCTR2005-001912-38-ESACROSS43