Isolated Hepatic Perfusion With Melphalan Followed By Chemotherapy in Treating Patients With Unresectable Colorectal Cancer That is Metastatic to the Liver

NCT ID: NCT00019760

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-04-30
• Study Completion Date: 2002-03-31

Brief 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.

PURPOSE: Phase II trial to study the effectiveness of melphalan given as an isolated hepatic perfusion followed by chemotherapy infused into the liver in patients who have unresectable colorectal cancer that is metastatic to the liver.

Detailed Description

OBJECTIVES: I. Determine the response rate and response duration in patients with unresectable colorectal cancer metastatic to the liver treated with isolated hepatic perfusion with melphalan followed by postoperative hepatic arterial chemotherapy.

II. Determine the patterns of recurrence in this patient population with this treatment regimen.

III. Evaluate the disease-free survival and overall survival in these patients.

IV. Evaluate health related quality of life and determine whether baseline correlates with the length of survival.

PROTOCOL OUTLINE: Patients undergo surgery and hyperthermic isolated hepatic perfusion with melphalan given intra-arterially over 60 minutes.

At six weeks post-hepatic perfusion, patients receive floxuridine and leucovorin calcium intra-arterially as a continuous infusion over 14 days. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed prior to study and then at each followup visit. Patients are followed every 3-4 months for 3 years and then every 6 months thereafter or until disease progression.

PROJECTED ACCRUAL:

A total of 50 patients will be accrued for this study.

Conditions

Recurrent Colon Cancer; Liver Metastases; Stage IV Rectal Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

floxuridine

Intervention Type: DRUG

leucovorin calcium

Intervention Type: DRUG

melphalan

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically or cytologically proven measurable metastatic colorectal cancer limited to the parenchyma of the liver No evidence of unresectable extrahepatic disease Limited resectable extrahepatic disease allowed Unresectable liver disease defined as: Greater than 3 sites of liver disease OR Bilobar disease OR Tumor abutting major vascular or ductal structures, impeding resection with preservation of liver function OR Limited extrahepatic disease No biopsy-proven cirrhosis No significant portal hypertension --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior biologic therapy for colorectal cancer and recovered Chemotherapy: At least 4 weeks since prior chemotherapy for colorectal cancer and recovered No prior intrahepatic arterial infusional therapy using floxuridine Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy for colorectal cancer and recovered Surgery: See Disease Characteristics Other: No concurrent immunosuppressive drugs No concurrent chronic anticoagulants --Patient Characteristics-- Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count greater than 100,000/mm3 Hematocrit greater than 27.0% WBC greater than 3,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL PT no greater than 2 seconds over upper limit of normal Elevated hepatic transaminases secondary to liver metastases allowed No veno-occlusive disease Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No congestive heart failure with LVEF less than 40% Pulmonary: No chronic obstructive pulmonary disease No other chronic pulmonary disease with pulmonary function test less than 50% predicted Other: No active infections HIV negative Body weight greater than 30 kg Not pregnant or nursing Negative pregnancy test

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

H. Richard Alexander, Jr.

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

Surgery Branch

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

99-C-0093

Identifier Type: -

Identifier Source: secondary_id

CDR0000067199

Identifier Type: -

Identifier Source: secondary_id

990093

Identifier Type: -

Identifier Source: org_study_id

NCT00001809

Identifier Type: -

Identifier Source: nct_alias