NCT00089401已完成2 期
A Phase II Trial Of Isolated Hepatic Perfusion (IHP) With Melphalan For Subjects With Metastatic Unresectable Colorectal Cancers Of The Liver With Disease Refractory To First Line Systemic Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy 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 unresectable colorectal cancer that has metastasized to the liver.
详细描述
OBJECTIVES:
Primary
- Determine the response and duration of response in patients with unresectable colorectal cancer metastatic to the liver and refractory to first-line systemic chemotherapy treated with isolated hepatic perfusion with melphalan.
Secondary
- Determine the pattern of recurrence (liver vs systemic) in patients treated with this regimen.
- Determine hepatic progression-free and overall survival in patients treated with this regimen.
- Determine the time to hepatic and systemic progression in patients treated with this regimen.
- Determine quality of life (QOL) in patients treated with this regimen.
- Correlate baseline QOL with length of survival in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed colorectal cancer
- •Metastatic disease limited to the parenchyma of the liver
- •Patients with limited sites of extrahepatic disease AND who have dominant life-limiting disease in the liver are considered eligible provided the extrahepatic sites can be treated with local ablative measures (e.g., resection or external beam radiotherapy)
- •No other evidence of unresectable extrahepatic disease by radiological studies
- •Unresectable hepatic disease defined by > 3 sites of disease in the liver, bilobar disease, or tumor abutting major vascular or ductal structures making anatomic resection with liver function preservation impossible
- •Measurable disease
- •Refractory to prior first-line systemic chemotherapy
- •Disease progression during or after completion of treatment with an irinotecan- or oxaliplatin-containing regimen for established hepatic metastases
- •Treatment failure is defined as disease progression evidenced by tumor growth OR new lesions on imaging modalities OR increasing carcinoembryonic antigen (CEA)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hematocrit > 27.0%
- •Platelet count > 100,000/mm^3
- •WBC > 3,000/mm^3
- •Bilirubin < 2.0 mg/dL
- •PT ≤ 2 seconds of the upper limit of normal
- •ALT and AST elevations secondary to metastatic disease allowed
- •Chronic active hepatitis B or C allowed provided there is no evidence of cirrhosis on pathology, radiologic studies, or physical exam
- •No history of veno-occlusive disease
- •No biopsy proven cirrhosis
- •No evidence of significant portal hypertension manifested by ascites, esophageal varices on endoscopy, or radiologic studies showing significant collateral vessels around the organs drained by the portal venous system
- •No other liver condition that would preclude study therapy
- •Creatinine ≤ 1.5 mg/dL OR
- •Creatinine clearance > 60 mL/min
- •Cardiovascular
- •LVEF ≥ 40%
- •No ischemic cardiac disease
- •No history of congestive heart failure
- •Chronic obstructive pulmonary disease or other chronic pulmonary disease allowed provided pulmonary function test ≥ 50% of predicted
- •Not pregnant or nursing
- •Negative pregnancy test
- •No active infection
- •Weight > 30 kg
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior biologic therapy for the malignancy and recovered
- •Chemotherapy
- •See Disease Characteristics
- •More than 4 weeks since prior chemotherapy for the malignancy and recovered
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •More than 4 weeks since prior radiotherapy for the malignancy and recovered
- •See Disease Characteristics
- 另有 2 项未显示
排除标准
- 未提供
结局指标
主要结局
Response
Duration of response
次要结局
- Patterns of tumor recurrence (liver vs systemic)
- Progression-free survival
- Overall survival
- Quality of life
研究者
研究点 (2)
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