Chemotherapy With or Without Isolated Hepatic Perfusion With Melphalan in Treating Patients With … (NCT00020501) | Clinical Trial Compass
CompletedPhase 3
Chemotherapy With or Without Isolated Hepatic Perfusion With Melphalan in Treating Patients With Colorectal Cancer That Has Spread to the Liver
United StatesStarted 2001-03
Plain-language 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. It is not yet known which chemotherapy regimen is most effective for colorectal cancer that has spread to the liver.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without isolated hepatic perfusion with melphalan in treating patients who have colorectal cancer that has spread to the liver.
Who can participate
Age range18 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic colorectal cancer of the parenchyma of the liver
* No evidence of extrahepatic disease (limited resectable extrahepatic disease allowed)
* Unresectable liver metastasis, as defined by the following:
* More than 3 sites of disease
* Bilobar disease
* Tumor abutting major vascular or ductal structures
* Measurable disease
* No biopsy-proven cirrhosis or evidence of significant portal hypertension manifested by ascites, esophageal varices, or collateral vessels around organs drained by the portal venous system
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Platelet count greater than 100,000/mm\^3
* Hematocrit greater than 27.0%
* WBC greater than 3,000/mm\^3
Hepatic:
* Bilirubin less than 2.0 mg/dL
* PT no greater than 2 seconds over upper limit of normal
* Elevations in transaminases secondary to metastatic disease allowed
* No veno-occlusive disease
* No active chronic hepatitis
* Hepatitis B or C allowed 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:
* No ischemic cardiac disease
* No prior congestive heart failure with LVEF less than 40%
Pulmonary:
* No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function test less than 50% of predicted
Ot…
Trial details
NCT IDNCT00020501
SponsorNational Institutes of Health Clinical Center (CC)