Isolated Hepatic Perfusion With Melphalan Followed by Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, leucovorin, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways may kill more tumor cells.

PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan followed by combination chemotherapy works in treating patients with unresectable liver metastases from colorectal cancer.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Calcium; Fluorouracil; Leucovorin; Levoleucovorin; Melphalan; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed colorectal cancer

• Metastatic disease limited to the parenchyma of the liver

• No evidence of unresectable extrahepatic disease by preoperative radiology

• Limited extra-hepatic disease and dominant life-limiting liver disease allowed provided extra-hepatic sites are treatable by local ablative measures (e.g., surgical resection or external beam radiotherapy)

• At least 40% hepatic replacement by tumor by axial CT scan or MRI

• Unresectable liver metastases, defined by 1 of the following:

• More than 3 sites of disease in the liver

• Bilobar disease

• Tumor abutting major vascular or ductal structures

• Measurable disease

• Previously untreated disease

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Hematocrit > 27.0%

• WBC > 3,000/mm^3

• Platelet count > 100,000/mm^3

Hepatic

• Bilirubin < 2.0 mg/dL

• PT < 2 seconds above upper limit of normal

• Elevated transaminase levels allowed if due to liver metastases

• No cirrhosis by biopsy

• No significant portal hypertension as manifested by any of the following:

• Ascites

• Esophageal varices by endoscopy

• Significant collateral vessels around the organs drained by the portal venous system by radiography

• No chronic active hepatitis

• Hepatitis B and C surface antigen negative

• No history of veno-occlusive disease

Renal

• Creatinine ≤ 1.5 mg/dL OR

• Creatinine clearance > 60 mL/min

Cardiovascular

• No ischemic cardiac disease

• No history of congestive heart failure

• LVEF > 40% by echocardiogram or stress thallium scan (for patients with cardiac disease)

Pulmonary

• No chronic obstructive pulmonary disease or other chronic pulmonary disease

• Pulmonary function tests ≥ 50% of predicted (for patients with pulmonary disease)

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Weight > 30 kg

• No active infection

• No peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Prior adjuvant chemotherapy (including leucovorin calcium, oxaliplatin, and fluorouracil) allowed provided it was administered > 6 months before liver metastases were diagnosed

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy for this malignancy and recovered

Surgery

• Not specified

Other

• No concurrent chronic anticoagulation therapy

• No concurrent immunosuppressive drugs