Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
Condition: Colorectal Cancer; Metastatic Cancer
MeSH terms: Colorectal Neoplasms
Intervention: floxuridine; fluorouracil; leucovorin calcium; adjuvant therapy; conventional surgery
Intervention description: Starting dose of 0.2 mg/kg/day for 14 consecutive days.; 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.; 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.; Chemotherapy given after hepatic resection; Hepatic resection
Intervention MeSH terms: Leucovorin; Fluorouracil; Floxuridine; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; liver metastases

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 drugs in different ways may
      kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of surgery followed by floxuridine plus
      systemic fluorouracil and leucovorin in treating patients with liver metastases from
      colorectal cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed colorectal carcinoma or radiologically confirmed colorectal
             carcinoma in a synchronous metastasis

          -  Intrahepatic metastases required

               -  No more than 15 metastases involving no more than 60% of functioning liver

          -  No extrahepatic disease unless:

               -  Resectable anastomotic or locally recurrent tumor

               -  Resectable mesenteric lymph node involvement in patients undergoing initial
                  resection of primary colorectal carcinoma

               -  Disease extension from liver metastasis amenable to en bloc resection (e.g.,
                  diaphragm wall, kidney, abdominal wall)

          -  No biopsy-proven chronic active hepatitis

        PATIENT CHARACTERISTICS:

        Age:

          -  Physiologic 18 to 70

        Performance status:

          -  Karnofsky 60%-100%

        Hematopoietic:

          -  AGC at least 1,500

          -  Platelets at least 100,000

        Hepatic:

          -  Bilirubin no greater than 2.0 mg/dL (unless reversibly obstructed by metastasis)

        Renal:

          -  Creatinine no greater than 2.0 mg/dL

        Other:

          -  No second malignancy within 5 years except adequately treated:

               -  Nonmelanomatous skin cancer

               -  In situ bladder cancer

               -  In situ cervical cancer

               -  No pregnant women

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  Prior mitomycin or nitrosoureas allowed

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior radiotherapy to the liver

          -  At least 3 weeks since radiotherapy and recovered

          -  Prior pelvic radiotherapy allowed

          -  No planned concurrent radiotherapy

        Surgery:

          -  Not specified