NCT01206049已完成2 期
Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- The fraction of patients alive and without progression at 6 months
研究概览
简要总结
The purpose of this study is to determine the rate of progression free survival of patients with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are treated with combination chemotherapy supplemented by biological agents panitumumab or bevacizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Histologically verified adenocarcinoma arisen from gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with the above and simultaneous radiologic findings consistent with cholangiocarcinoma
- •Minimum 18 years of age
- •Curative treatment currently not an option (operation, stereotactic radiation treatment or similar)
- •KRAS analyzed and found wild-type (wt)
- •Performance status 0-2
- •Evaluable disease according to RECIST, i.e. the disease need not be measurable
- •Hematology: ANC ≥1.5x10^9/l. Thrombocytes ≥ 100x10^9/l
- •Biochemistry: Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal level.
- •Creatinine ≤ upper normal level. At raised creatinine level the measured or calculated GFR must be at least 50% of the lower normal level
- •Fertile women must present a negative pregnancy test and use secure birth control during and 6 months after treatment. Men with fertile partners must also take care of secure birth control.
- •Written and orally informed consent
排除标准
- •Previous cytostatic treatment of inoperable cholangiocarcinoma
- •Adjuvant or neoadjuvant chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to treatment start
- •Other concomitant experimental treatment
- •Severe medical disease such as considerable heart disease, serious active infection or other disease making the patient unfit for study participation as assessed by investigator
- •Other malignant disease within 5 years prior to enrolment except from non-melanotic skin cancer and carcinoma in situ cervicis uteri
- •Interstitial pneumonitis or subsequent pulmonary fibrosis
- •Pregnant or breastfeeding women
- •Large-scale surgical intervention, excision biopsy or significant traumatic lesions within 28 days prior to treatment start or presumption that large-scale surgery will become necessary during study treatment.
- •Significant non-healing wound or ulcers
- •Active hemorrhage or increased risk of hemorrhage (e.g. tumor invasion in large vessels or known esophagus varices)
- •Known hypersensitivity to panitumumab, bevacizumab or any of the auxiliary agents
- •Grade IV fistulas
- •Uncontrolled hypertension, i.e. symptomatic hypertension or non-medically stabilized hypertension >160/100
- •Haemoptysis > 2.5 ml within 2 weeks prior to enrolment
- •Previous serious and unexpected reactions or know hypersensitivity to two or more of the applied cytostatics
研究组 & 干预措施
Combination chemotherapy + panitumumab
Experimental
干预措施: Gemcitabine (Drug)
Combination chemotherapy + panitumumab
Experimental
干预措施: Oxaliplatin (Drug)
Combination chemotherapy + panitumumab
Experimental
干预措施: Capecitabine (Drug)
Combination chemotherapy + panitumumab
Experimental
干预措施: Panitumumab (Drug)
Combination chemotherapy + bevacizumab
Experimental
干预措施: Gemcitabine (Drug)
Combination chemotherapy + bevacizumab
Experimental
干预措施: Oxaliplatin (Drug)
Combination chemotherapy + bevacizumab
Experimental
干预措施: Capecitabine (Drug)
Combination chemotherapy + bevacizumab
Experimental
干预措施: Bevacizumab (Drug)
结局指标
主要结局
The fraction of patients alive and without progression at 6 months
时间窗: 6 months from enrollment date
次要结局
- Response rate before cross-over(6 months after enrollment or earlier in case of progression)
- Overall survival(6 months)
- Progression free survival and response rate after cross-over(6 months)
研究者
研究点 (1)
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