Isolated Hepatic Perfusion With Melphalan in Treating Patients With Unresectable Colorectal Cancer That Has Metastasized to the Liver

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Melphalan

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