Isolated Hepatic Perfusion With Melphalan Followed by Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, liver metastases
Eligibility 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
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support