Isolated Hepatic Perfusion With Melphalan in Treating Patients With Unresectable Colorectal Cancer That Has Metastasized to the Liver
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, liver metastases
Eligibility Criteria
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: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Hematocrit > 27.0% Platelet count > 100,000/mm^3 WBC > 3,000/mm^3 Hepatic 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 Renal Creatinine ≤ 1.5 mg/dL OR Creatinine clearance > 60 mL/min Cardiovascular LVEF ≥ 40% No ischemic cardiac disease No history of congestive heart failure Pulmonary Chronic obstructive pulmonary disease or other chronic pulmonary disease allowed provided pulmonary function test ≥ 50% of predicted Other 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 Surgery See Disease Characteristics Other No concurrent immunosuppressive drugs No concurrent chronic anticoagulation therapy
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office