Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- The maximum tolerated dose of gemcitabine when given in combination with therasphere
研究概览
简要总结
Therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer.
The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with TheraSphere (radioactive beads that are injected directly into the blood vessel supplying the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic cancer or cholangiocarcinoma (bile duct tumors) involving the liver.
详细描述
Patients with liver predominant cholangiocarcinoma or pancreatic cancer will be considered for the trial. The patients wre being treated in groups of thre patients. Each three patients receive a pre-specified dose of gemcitabine with full dose radioembolization using theraspheres. If no significant side effects are observed then three additional three patients will be treated with a higher dose of gemcitabine. The purpose to identify the highest dose of gemcitabine that can be safely combined with theraspheres.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of pancreatic cancer or cholangiocarcinoma
- •Liver predominant disease defined as
- •Cholangiocarcinoma: liver disease should be unresectable
- •Limited extra hepatic metastasis defined as: i. Lung metastasis: 6 or less nodules with no nodule greater than 1.5 cm.
- •ii. Abdominal lymph nodes iii. Pancreatic primary as long as the size is less than 4 cm in size iv. Bone metastasis
- •No prior systemic therapy for advanced stage disease
- •Measurable target tumors using standard imaging techniques
- •Lung shunting less than 20%
- •ECOG performance status 0-1 (See Appendix )
- •Age ≥ 18 years
- •No other investigational agents while on protocol
- •Signed informed consent
排除标准
- •Inadequate hepatic function: AST/ALT > five times upper limit of normal, Bilirubin >2.0 mg/dl or history of hepatic encephalopathy
- •Inadequate renal function Creatinine > 2.0 mg/dL
- •Inadequate bone marrow function: platelets < 100,000/mL or absolute neutrophil count <1500/mL
- •Contraindication to angiography
- •Prior external beam radiotherapy to the upper abdomen
- •Clinical evidence of peritoneal metastasis or ascites
- •Patients with extensive tumor replacement in the liver defined as >50% of liver involved with tumor
- •Any serious ongoing extra-hepatic disease such as infections.
研究组 & 干预措施
Gemcitabine with TheraSphere
干预措施: Gemcitabine with TheraSphere (Drug)
结局指标
主要结局
The maximum tolerated dose of gemcitabine when given in combination with therasphere
时间窗: 28 days
Patients will receive full dose therasphere. The gemcitabine dose will start out low and the dose will increase after first 3 patients if no significant side effects are observed. The investigators will continue to increase the dose of gemcitabine as long as the investigators do not observe side effects or until we reach full dose of gemcitabine.
次要结局
- Toxicities (side effects) experienced by patients on the trial(90 days)
- Tumor response rate when treated with gemcitabine and Therasphere using CT scan and F18-FDG-PET scan .(78 days)
- The progression free of patients treated on the trial(12 months)