NCT01379807Unknown2 期
A Phase II Trial to Assess the Efficacy and Safety of Panitumumab Combined With Docetaxel and Cisplatin as a First-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Grupo Gallego de Investigaciones Oncologicas9 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 55
- 试验地点
- 9
- 主要终点
- Objective response rate
研究概览
简要总结
The clinical hypothesis of this study is that the addition of Panitumumab to the first line treatment combination of docetaxel plus cisplatin will provide benefit to patients with advanced gastric or gastroesophageal junction adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent Inclusion:
- •Age ≥ 18 years
- •Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with advanced unresectable or metastatic disease.
- •Measurable disease per the revised RECIST (Response Evaluation Criteria in Solid Tumor) Guidelines
- •ECOG performance score of 0 - 2
- •Within seven days prior to initiating study treatment:Haematology:Neutrophils ≥ 1.5x109, Platelets ≥ 100x10/ L, Hemoglobin ≥ 9g/dL. Hepatic functions: Total bilirubin ≤ 1.5 time the upper normal limit (UNL),ASAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases,ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases. Renal function: creatinine clearance ≥50 mL/min. Metabolic Function: Magnesium ≥ lower limit of normal, Calcium ≥ lower limit of normal.
排除标准
- •Prior chemotherapy or other anticancer therapy for advanced unresectable or metastatic disease (1st line)
- •Prior anti-EGFR antibody therapy (e.g. cetuximab) or treatment with small molecule EGFR inhibitors (e.g. erlotinib).
- •HER2-positive tumor (centrally assessed)
- •Past or current history (within the last 5 years prior to treatment start) of other malignancies except gastric cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible)
- •Current or prior history of central nervous system metastases
- •Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study
- •Known hypersensitivity to any of the study drugs
- •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
- •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •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.
研究组 & 干预措施
panitumumab + docetaxel + cisplatino
Experimental
干预措施: panitumumab + docetaxel + cisplatino (Drug)
结局指标
主要结局
Objective response rate
时间窗: 3 years
To estimate the objective response rate in patients treated with docetaxel, cisplatin and panitumumab as first-line treatment in advanced gastric or gastroesophageal junction adenocarcinoma.
次要结局
- Time to response(3 years)
- Progression free survival(3 years)
- Duration of response(3 years)
- Time to progression(3 years)
- Safety profile(3 years)
- Disease control rate(3 years)
- Time to treatment failure(3 years)
- Duration of stable disease(3 years)
- Overall survival(3 years)
- Exploratory Objectives(3 years)
研究者
研究点 (9)
Loading locations...
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