Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving 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 primary unresectable liver cancer or liver metastases.

Detailed Description
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OBJECTIVES: Determine response rate, duration of response, and patterns of recurrence in patients with primary or metastatic, unresectable cancers of the liver after treatment with isolated hepatic perfusion with melphalan. Determine the disease-free and overall survival of patients treated with this regimen. OUTLINE: Patients who are otherwise eligible undergo an exploratory laparotomy of the peritoneal cavity. Patients with peritoneal seeding, unresectable extrahepatic metastases, or unresectable pathologically-involved lymph nodes outside area of portahepatis do not receive treatment. Remaining patients receive isolated hepatic perfusion with melphalan. Liver perfusion proceeds for 1 hour. Patients are followed at 6 weeks, every 3 months for 2 years, and then every 4 months until disease progression. PROJECTED ACCRUAL: A maximum of 67 patients will be accrued for this study.

Official Title
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A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver

Conditions
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Colorectal Cancer, Islet Cell Tumor, Liver Cancer, Metastatic Cancer, Neuroendocrine Carcinoma

Intervention / Treatment
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* Drug: isolated perfusion
* Drug: melphalan
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically proven liver cancer meeting 1 of the following criteria: Primary unresectable hepatocellular or cholangiocellular carcinoma Metastatic cancer to the liver originating from one of the following: Intraocular melanoma (closed to accrual as of 10/17/03) Islet cell carcinoma Adenocarcinoma of the colon or rectum limited to parenchyma of the liver No evidence of other unresectable extrahepatic colorectal metastasis Other neuroendocrine tumors, such as carcinoid tumors Measurable disease PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count greater than 100,000/mm^3 Hematocrit greater than 27.0% WBC at least 2,500/mm^3 Hepatic: Bilirubin less than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome) PT no greater than 2 seconds above upper limit of normal Elevated SGOT and SGPT allowed if not due to hepatitis No biopsy-proven cirrhosis or evidence of significant portal hypertension No prior or concurrent veno-occlusive disease Patients with positive hepatitis B or C surface antigen serology and chronic active hepatitis are eligible 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: Congestive heart failure allowed if LVEF ≥ 40% Pulmonary: No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function tests less than 50% predicted for age Other: Weight greater than 30 kg Not pregnant or nursing Negative pregnancy test No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 month since prior anticancer biologic therapy and recovered Chemotherapy: At least 1 month since prior anticancer chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 1 month since prior anticancer radiotherapy and recovered Surgery: Not specified Other: Prior intrahepatic arterial infusion therapy allowed No chronic use of anticoagulants No concurrent immunosuppressive therapy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: isolated perfusion|nan|
|Drug: melphalan|nan|
|Procedure: conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Duration of response |  |  | 
| Patterns of recurrence |  |  | 
| Disease-free survival |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, recurrent islet cell carcinoma, adult primary hepatocellular carcinoma, adenocarcinoma of the colon, adenocarcinoma of the rectum, liver metastases, adult primary cholangiocellular carcinoma, advanced adult primary liver cancer, recurrent childhood liver cancer, childhood hepatocellular carcinoma, stage III childhood liver cancer, stage IV childhood liver cancer, neuroendocrine carcinoma