EUCTR2009-014336-38-DE进行中（未招募）不适用
A randomized, placebo-controlled phase II trial investigating SUNITINIB versus placebo in patients with chemorefractory advanced adenocarcinoma of the stomach or lower esophagus treated with chemotherapy FOLFIRI - SUN-CASE
niversitätsmedizin der Johannes Gutenberg-University Mainz0 个研究点开始时间: 2009年8月20日最近更新:
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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
- •Signed and dated informed consent before the start of specific protocol procedures;
- •Histological proven gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction or lower esophagus;
- •Failure of any prior chemotherapy (docetaxel and/or platinum-based chemotherapy); but patient has not previously received FOLFIRI treatment;
- •Measurable metastatic disease according to the RECIST 1.1 criteria. If locally recurrent disease, it must be associated with at least one measurable lymph node (> 20 mm by CT scan or > 10 mm with spiral CT);
- •Age: = 18 years;
- •Karnofsky index 100 – 70 %
- •Life expectancy > 12 weeks;
- •Adequate hematological, hepatic and renal functions: ANC = 1.5 x 109/L, platelets = 100 x 109/L; creatinine = 2 x UNL; total bilirubin = 3 x UNL, AST (SGOT) and ALAT (SGPT) = 3 x UNL; in case of liver metastases: total bilirubin = 6 x UNL, AST (SGOT) and ALAT (SGPT) = 6 x UNL;
- •At least 3 weeks from previous docetaxel– and/or platinum-based chemotherapy;
- •Recovery from hematological side effects (CTC grade < 1) and non-hematological side effects (CTC grade = 1) of any prior therapy (except oxaliplatine induced neuropathy CTC grade = 2);
- •Able to comply with scheduled assessments and with management of toxicity;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •History of another primary malignancy =3 years, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix;
- •Any prior palliative radiotherapy of the target lesions;
- •Concurrent treatment with any other medicinal anti-cancer therapy;
- •Prior treatment with a VEGF, VEGFR or RTK inhibitor, or prior enrolment on this study (some inhibitors may be allowed after obtaining Sponsor approval);
- •Known allergic/hypersensitivity reaction to any of the components of the treatment;
- •Treatment with potent CYP3A4 inhibitor within 7 days of Sunitinib/placebo dosing or with potent CYP3A4 inducer within 12 days of Sunitinib/placebo dosing; except dexamethasone for the prevention of chemotherapy induced emesis;
- •Other serious illness or medical conditions within the last 12 months prior to study drug administration:
- •-Unstable cardiac disease despite treatment; myocardial infarction within 12 months prior to study entry; congestive heart failure NYHA grade 3 and 4;
- •-Hypertension that cannot be controlled by medication (>150/100 mmHg) despite optimal medical therapy;
- •-Ongoing cardiac dysrhythmias of NCI CTCAE grade = 2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females;
- •-History of significant neurologic or psychiatric disorders including dementia or seizures;
- •-Active uncontrolled infection;
- •-History of clinically significant bleeding within the past 6 months, including hemoptysis or haematuria, or underlying coagulopathy;
- •-Active disseminated intravascular coagulation;
- •-Cerebrovascular accident including transient ischemic attack;
- •-Pulmonary embolus;
- •-Bowel obstruction or chronic diarrhoea, history or presence of inflammatory enteropathy or extensive intestinal resection (> hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis;
- •-Peptic ulcer disease;
- •-History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrolment, unless affected area has been removed surgically;
- •Known deficit in DPD;
- •Hypercalcemia not controlled by bisphosphonates;
- •Contraindications to the use of atropine;
- •Pregnant or lactating women; female patients who are pregnant or lactating or men and women of reproductive potential not willing or not able to employ an effective method of birth control/contraception to prevent pregnancy during treatment and for 3 months after discontinuing study treatment;
- •Known drug abuse/alcohol abuse;
- •Current, recent, or planned participation in an experimental treatment drug study other than this protocol;
- •Major surgical procedure, open biopsy or significant traumatic injury within 4 weeks before starting treatment; anticipation of need for major surgical procedure (e.g. impending bowel obstruction) during the course of the study;
- •History of other medical or psychiatric condition, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications.
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