A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with primary unresectable liver cancer or liver metastases.
详细描述
OBJECTIVES:
- Determine response rate, duration of response, and patterns of recurrence in patients with primary or metastatic, unresectable cancers of the liver after treatment with isolated hepatic perfusion with melphalan.
- Determine the disease-free and overall survival of patients treated with this regimen.
OUTLINE: Patients who are otherwise eligible undergo an exploratory laparotomy of the peritoneal cavity. Patients with peritoneal seeding, unresectable extrahepatic metastases, or unresectable pathologically-involved lymph nodes outside area of portahepatis do not receive treatment. Remaining patients receive isolated hepatic perfusion with melphalan. Liver perfusion proceeds for 1 hour.
Patients are followed at 6 weeks, every 3 months for 2 years, and then every 4 months until disease progression.
PROJECTED ACCRUAL: A maximum of 67 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically proven liver cancer meeting 1 of the following criteria:
- •Primary unresectable hepatocellular or cholangiocellular carcinoma
- •Metastatic cancer to the liver originating from one of the following:
- •Intraocular melanoma (closed to accrual as of 10/17/03)
- •Islet cell carcinoma
- •Adenocarcinoma of the colon or rectum limited to parenchyma of the liver
- •No evidence of other unresectable extrahepatic colorectal metastasis
- •Other neuroendocrine tumors, such as carcinoid tumors
- •Measurable disease
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count greater than 100,000/mm^3
- •Hematocrit greater than 27.0%
- •WBC at least 2,500/mm^3
- •Bilirubin less than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)
- •PT no greater than 2 seconds above upper limit of normal
- •Elevated SGOT and SGPT allowed if not due to hepatitis
- •No biopsy-proven cirrhosis or evidence of significant portal hypertension
- •No prior or concurrent veno-occlusive disease
- •Patients with positive hepatitis B or C surface antigen serology and chronic active hepatitis are eligible provided there is no evidence of cirrhosis
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •Congestive heart failure allowed if LVEF ≥ 40%
- •No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function tests less than 50% predicted for age
- •Weight greater than 30 kg
- •Not pregnant or nursing
- •Negative pregnancy test
- •No active infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 1 month since prior anticancer biologic therapy and recovered
- •Chemotherapy:
- •At least 1 month since prior anticancer chemotherapy and recovered
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 1 month since prior anticancer radiotherapy and recovered
- •Not specified
- •Prior intrahepatic arterial infusion therapy allowed
- •No chronic use of anticoagulants
- •No concurrent immunosuppressive therapy
排除标准
- 未提供
结局指标
主要结局
Response rate
Duration of response
Patterns of recurrence
Disease-free survival
Overall survival
次要结局
未报告次要终点