Chemotherapy With or Without Isolated Hepatic Perfusion With Melphalan in Treating Patients With Colorectal Cancer That Has Spread to the Liver

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells. It is not yet known which chemotherapy regimen is most effective for colorectal cancer that has spread to the liver.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without isolated hepatic perfusion with melphalan in treating patients who have colorectal cancer that has spread to the liver.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Floxuridine; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Melphalan

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic colorectal cancer of the parenchyma of the liver

• No evidence of extrahepatic disease (limited resectable extrahepatic disease allowed)

• Unresectable liver metastasis, as defined by the following:

• More than 3 sites of disease

• Bilobar disease

• Tumor abutting major vascular or ductal structures

• Measurable disease

• No biopsy-proven cirrhosis or evidence of significant portal hypertension manifested by ascites, esophageal varices, or collateral vessels around organs drained by the portal venous system

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count greater than 100,000/mm^3

• Hematocrit greater than 27.0%

• WBC greater than 3,000/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL

• PT no greater than 2 seconds over upper limit of normal

• Elevations in transaminases secondary to metastatic disease allowed

• No veno-occlusive disease

• No active chronic hepatitis

• Hepatitis B or C allowed provided there is no evidence of cirrhosis

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• No ischemic cardiac disease

• No prior congestive heart failure with LVEF less than 40%

Pulmonary:

• No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function test less than 50% of predicted

Other:

• No active infections

• Not pregnant or nursing

• Negative pregnancy test

• Weight greater than 30 kg

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior biologic therapy for disease and recovered

Chemotherapy:

• At least 4 weeks since prior chemotherapy for disease and recovered

• No prior intrahepatic artery infusion therapy with floxuridine

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy for disease and recovered

Surgery:

• Not specified

Other:

• No concurrent immunosuppressive drugs

• No concurrent chronic anticoagulants