Colon Cancer Clinical Trial

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

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.

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Full Description

OBJECTIVES:

Primary

Determine the response and duration of response in patients with unresectable colorectal cancer metastatic to the liver and refractory to first-line systemic chemotherapy treated with isolated hepatic perfusion with melphalan.

Secondary

Determine the pattern of recurrence (liver vs systemic) in patients treated with this regimen.
Determine hepatic progression-free and overall survival in patients treated with this regimen.
Determine the time to hepatic and systemic progression in patients treated with this regimen.
Determine quality of life (QOL) in patients treated with this regimen.
Correlate baseline QOL with length of survival in patients treated with this regimen.

OUTLINE: Patients undergo a limited laparotomy to determine if extrahepatic disease that was not visualized during preoperative scanning is present. Patients found to have peritoneal seeding or unresectable extrahepatic metastatic disease not previously visualized on scans do not receive isolated hepatic perfusion (IHP). Remaining patients undergo IHP with melphalan and hyperthermia therapy. Liver perfusion continues for 1 hour.

Quality of life is assessed at baseline, 6 weeks, and then every 3-4 months for 3 years.

Patients are followed at 6 weeks, every 3-4 months for 3 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.

View Eligibility Criteria

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

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

8

Study ID:

NCT00089401

Recruitment Status:

Completed

Sponsor:

National Institutes of Health Clinical Center (CC)

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There is 1 Location for this study

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Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda Maryland, 20892, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

8

Study ID:

NCT00089401

Recruitment Status:

Completed

Sponsor:


National Institutes of Health Clinical Center (CC)

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