EUCTR2007-005796-34-DE进行中（未招募）不适用
A randomized, double-blind, multicenter phase II trial with gemcitabine plus sorafenib versus gemcitabine plus placebo in patients with chemo-naive advanced or metastatic adenocarcinoma of the biliary tract - CC-GEMSO-2007
niversität Mainz, I. Medizinische Klinik und Poliklinik0 个研究点开始时间: 2008年1月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Male and female patients aged 18 years and older
- •- Signed and dated informed consent before the start of specific protocol procedures
- •- Adenocarcinoma of the gallbladder or intrahepatic bile ducts or histologically proven hepatic metastases of an earlier resected and histologically proven biliary tract cancer
- •oNot amenable to curative surgical resection
- •oWith at least one unidimensionally measurable target lesion in non-irradiated (or treated by photodynamic therapy, PDT) area (largest diameter >/= 1 cm (spiral CT scan or MRI) or >/= 2 cm (conventional CT scan),
- •oWith pain and biliary obstruction controlled
- •oCytologically or histologically confirmed
- •Note : in case of uncertain biliary tract origin (e.g., intrahepatic CCs), inclusion is possible if
- •iv)extensive search for primary (thoracic and abdomino pelvic CT scan, colonoscopy, upper digestive endoscopy, serum PSA level for men or mammography for women, and FDG-PET if possible) is negative
- •v)histological examination is consistent with bile duct adenocarcinoma, with IHC positive for cytokeratin 7 and 19 and negative for cytokeratin 20 [Shimonishi, 2000].
- •vi)No histologically evidence of hepatocellular carcinoma (HCC)
- •-No prior palliative (radio)-chemotherapy (gemcitabine or fluoropyrimidine-based chemotherapy)
- •iii)previous adjuvant chemotherapy is allowed (completed since = 6 months if containing gemcitabine or platinum salts);
- •iv)previous irradiation (external radiotherapy, brachytherapy, chemoembolization) and PDT are allowed provided that there is at least one unidimensionally measurable target lesion in untreated area
- •-Resolution of all side effects of prior surgical procedures to grade = 1 (except for the laboratory values specified below)
- •-At least 4 weeks from any major surgery (at first dose of study drug)
- •-ECOG Performance Status of 0-2
- •-Life expectancy of at least 12 weeks
- •-Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •-Hemoglobin > 9.0 g/dl
- •-Absolute neutrophil count (ANC) >1,500/mm3
- •-Platelet count = 100,000/µl
- •-Total bilirubin < 3 times the upper limit of normal
- •-ALT and AST < 5 x upper limit of normal
- •-prothrombin rate > 60% or INR < 1.5
- •iii)intravenous vitamin K1 should be administered to patients with current or recent history of jaundice or bile duct obstruction and abnormal prothrombin rate or INR prior to assess prothrombin rate or INR
- •iv)Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists
- •-Alkaline phosphatase < 4 x ULN
- •-Lipase/Amylase < 2.5 x upper limit of normal
- •-Serum creatinine < 1.5 x upper limit of normal; creatinin clearance at least 45 ml/min
- •-Patients must be able to swallow sorafenib capsules
- •-Patients who understand the nature of the trial and are willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
- •-Female patients who are capable of bearing children must have a negative pregnancy test result (serum or urine) at study entry. All women included in the study must be surgically sterile or postmenopausal or agree to employ adequate birth control measures for the duration of the study and two months post
排除标准
- •-Surgery (except diagnostic biopsy), external radiotherapy, brachytherapy, or PDT within 30 days prior to start of treatment
- •-Other tumor type than adenocarcinoma (e.g. leiomyosarcoma, lymphoma) or a second cancer except in patients with squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix which has been effectively treated. Patients curatively treated and disease free for at least 5 years will be discussed with the sponsor before inclusion
- •-History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
- •-Any of the following within the 12 months prior to starting the study treatment:, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
- •-Ongoing cardiac dysrhythmias of grade >/=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females
- •-Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy)
- •-History of HIV infection
- •-Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- •-Known Central Nervous System tumors including metastatic brain disease
- •-Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- •-History of organ allograft
- •-Patients with evidence or history of bleeding diasthesis
- •-Active disseminated intravascular coagulation, or patients prone to thromboembolism
- •-Patients undergoing renal dialysis
- •-Pregnant or breast-feeding patients
- •-Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
- •-Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- •-Known or suspected allergy to the investigational agent or any agent given in association with this trial
研究者
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