Clinical trial NCT00043004 (phase 2, status: terminated)
Conditions: colorectal cancer, metastatic cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: folfox regimen, fluorouracil, leucovorin calcium, oxaliplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Unresectable liver metastases secondary to colorectal adenocarcinoma, including:

               -  Metastases that cannot be radically resected due to size, location, or number of
                  deposits

               -  Metastases invading right and left branches of hepatic artery or portal vein

               -  Metastases extended to the 3 main hepatic veins

          -  No detectable extra-hepatic disease

          -  Fewer than 10 metastatic deposits on liver

          -  Total metastatic involvement of liver no more than 50%

          -  Adequate treatment of all metastatic lesions deemed possible either by radiofrequency
             interstitial ablation (RFA) alone or by a combination of resection of resectable
             lesions and RFA of the remaining unresectable lesions

               -  Maximum diameter of 4 cm for lesions to be treated with RFA

               -  No maximum diameter of lesions to be resected as long as negative resection
                  margins are obtainable

          -  If synchronous liver metastases, must have undergone prior resection of primary tumor

        PATIENT CHARACTERISTICS:

        Age

          -  18 to 80

        Performance status

          -  WHO 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count greater than 1,500/mm^3

          -  Platelet count greater than 100,000/mm^3

          -  No bleeding disorder or coagulopathy or need for full-dose anticoagulation

        Hepatic

          -  Bilirubin less than 3 times upper limit of normal (ULN)

          -  Alkaline phosphatase less than 3 times ULN

        Renal

          -  Creatinine less than 2 times ULN

          -  Protein < 0.5 g/24 hr urine collection if proteinuria positive by dipstick

        Cardiovascular

          -  No uncontrolled congestive heart failure

          -  No uncontrolled angina pectoris

          -  No uncontrolled hypertension

          -  No uncontrolled arrhythmia

          -  No myocardial infarction within the past 12 months

          -  No cerebrovascular accident or transient ischemic attack within the past 6 months

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No greater than grade 1 peripheral neuropathy

          -  No significant neurologic or psychiatric disorder

          -  No active infection

          -  No contraindication to the use of fluorouracil, leucovorin calcium, oxaliplatin, or
             bevacizumab

          -  No other malignancy within the past 10 years except nonmelanoma skin cancer or
             carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy except for metastatic disease confined to the liver

               -  Prior fluorouracil, leucovorin calcium, and oxaliplatin allowed if administered
                  for at least 3 courses (2 weeks each) but no longer than 3 months with at least
                  stabilization of disease achieved

          -  Prior adjuvant chemotherapy for primary cancer allowed except for patients who
             received oxaliplatin and have been diagnosed with metastatic disease within 12 months
             after completion of adjuvant treatment

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  More than 28 days since major surgery or open biopsy past 28 days

          -  More than 28 days since significant traumatic injury

        Other

          -  No other concurrent investigational treatment

          -  No other concurrent anticancer therapy