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.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 51
- 试验地点
- 9
- 主要终点
- Objective response rate
研究概览
简要总结
Investigators propose to study the effect of panitumumab when combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in previously untreated patients with advanced cancer of the stomach.
详细描述
Investigators propose a phase I/II study in order to evaluate the effect of panitumumab when combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in chemotherapy - naive patients with advanced cancer of the stomach.
Investigators hypothesize that the addition of panitumumab to DCF regimen in advanced cancer of the stomach and gastroesophageal junction is feasible, well tolerated and could achieve an objective response rate of greater than 40%.
The 2-weekly schedule of DCF will be used as chemotherapy since a recently presented trial demonstrated a comparable efficacy but a more favourable toxicity profile comparable to the 3-weekly schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven inoperable locally advanced or metastatic adenocarcinoma of the stomach (including adenocarcinoma of the gastrooesophageal junction)
- •Patient's age between 20 and 70 years old
- •Measurable disease defined by RECIST criteria
- •Patients with non-measurable disease could be enrolled in the phase I part of the study
- •ECOG performance status ≤ 1
- •Hgb ≥ 8g/dL, WBC ≥ 3 x 109/L , neutrophils count ≥ 1.5 x 109/L , platelets ≥100 x 109/L, Creatinine clearance ≥50 mL/min, Total bilirubin ≤ 1.5 X UNL, AST, ALT and ALP ≤ 2.5 x UNL
- •No prior chemotherapy or more than 6 months from adjuvant chemotherapy or chemo-radiation
- •Estimated life expectancy more than 3 months
- •Written informed consent
排除标准
- •Gastrointestinal bleeding
- •Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort
- •CNS metastases
- •History of hypersensitivity to fluoropyrimidines, docetaxel or platinum compounds
- •Any previous chemotherapy or radiotherapy for advanced disease
- •Patient pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
- •Patient (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
- •Known hypersensitivity reaction to the component of the treatment
- •Active infection or malnutrition or bowel obstruction
- •Legal incapacity or limited legal capacity
- •Definite contraindications for the use of corticosteroids
- •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- •Chronic inflammation of the bowel
- •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
- •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
- •A second primary tumor other than non-melanoma skin cancer or in situ cervical cancer
研究组 & 干预措施
1
Panitumumab plus DCF
干预措施: Pazopanib (Drug)
结局指标
主要结局
Objective response rate
时间窗: Every 8 weeks
Patients will be followed for disease evaluation every eight (8) weeks from the first day of chemotherapy until the first documentation of disease progression
次要结局
- Maximum Tolerated Dose of the combination(Up to 4 weeks)
- Progression Free Survival(1 year)
- Overall Survival(1 year)