EUCTR2009-015758-39-GR进行中（未招募）不适用
Phase I/II, Multicenter, Single-Arm Clinical Trial of Panitumumab in Combination with Cisplatin, Fluourouracil and Docetaxel (DCF) in Locally Advanced or Metastatic Cancer of the Stomach and Gastro-oesophageal junction. - N/A
Hellenic Oncology Research Group (HORG)0 个研究点开始时间: 2010年10月4日最近更新:
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
- •1. Histologically proven inoperable locally advanced or metastatic adenocarcinoma of the stomach (including adenocarcinoma of the gastrooesophageal junction)
- •2. Age between 20 and 70 years old
- •3. Measurable disease defined by RECIST
- •4. Patients with non-measurable disease could be enrolled in the phase I part of the study.
- •5. ECOG performance status = 1
- •6. Hgb = 8g/dL, WBC = 3 x 109/L , neutrophils count = 1.5 x 109/L , platelets =100 x 109/L ,
- •7. Creatinine clearance =50 mL/min
- •8. Total bilirubin = 1.5 X UNL
- •9. AST, ALT and ALP = 2.5 x UNL
- •10. No prior chemotherapy or more than six months from adjuvant chemotherapy or chemoradiation
- •11. Estimated life expectancy more than 3 months
- •12. Paraffin-embedded block available for K-RAS central mutation analysis
- •13. Written informed consent
- •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. Gastrointestinal bleeding
- •2. Clinically relevant, symptomatic excessive amounts of ascites resulting in patient’s discomfort
- •3. CNS metastases
- •4. History of hypersensitivity to fluoropyrimidines, docetaxel or platinum compounds
- •5. Any previous chemotherapy or radiotherapy for advanced disease
- •6. Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •7. Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
- •8. Known hypersensitivity reaction to the component of the treatment.
- •9. Active infection or malnutrition or bowel obstruction.
- •10. Legal incapacity or limited legal capacity
- •11. Definite contraindications for the use of corticosteroids
- •12. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •13. Chronic inflammation of the bowel.
- •14. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrollment
- •15. Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent.
- •16. A second primary tumor other than non-melanoma skin cancer or in situ cervical cancer.
研究者
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