Clinical trial NCT00118105 (phase 2, status: withdrawn)
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: capecitabine, 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
Reason stopped: 
    budget constraints
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of hepatic metastases secondary to colorectal cancer by percutaneous hepatic
             biopsy

          -  Resectable hepatic metastases by any of the following:

               -  Minor resection (i.e., less than a hemihepatectomy)

               -  Major resection (i.e., hemihepatectomy or extended hepatectomy)

               -  Bilobar resection (including atypical resection)

          -  Synchronous primary tumor and hepatic metastases allowed

          -  Radiologic evidence of hepatic metastases by multiphasic contrast-enhanced spiral CT
             scan

          -  Resectable primary colorectal cancer that is in place allowed

          -  Measurable disease

          -  No evidence of extrahepatic metastases by chest x-ray or CT scan of the chest

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Hemoglobin ≥ 9.0 g/dL

          -  WBC ≥ 3,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

        Hepatic

          -  Bilirubin ≤ 2 times upper limit of normal (ULN)

          -  SGOT or SGPT ≤ 2.5 times ULN

        Renal

          -  Creatinine clearance ≥ 60 mL/min

          -  Urine protein/creatinine ratio < 1 OR

          -  Urine protein < 1 g by 24-hour urine collection

        Cardiovascular

          -  No uncontrolled hypertension (i.e., blood pressure > 150/90 mm Hg)

               -  History of hypertension allowed provided it is well controlled on a stable
                  regimen of anti-hypertensive therapy

          -  No arterial thromboembolic event within the past 12 months, including any of the
             following:

               -  Transient ischemic attack

               -  Cerebrovascular accident

               -  Unstable angina

               -  Myocardial infarction

          -  No peripheral vascular disease ≥ grade 2

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No pre-existing peripheral neuropathy ≥ grade 2

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  More than 6 months since prior adjuvant chemotherapy for the primary tumor

          -  No prior systemic chemotherapy for metastatic disease

          -  No prior hepatic artery infusion chemotherapy for metastatic disease

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy for metastatic disease

        Surgery

          -  More than 7 days since prior colonoscopy or fine needle aspiration

          -  More than 28 days since prior major invasive surgery or open biopsy

        Other

          -  At least 4 weeks since prior and no concurrent sorivudine or brivudine

          -  No prior radiofrequency ablation for metastatic disease

          -  No prior cryotherapy for metastatic disease

          -  No other prior ablative techniques for metastatic disease

          -  No concurrent cimetidine

               -  Concurrent ranitidine or other drug from a different antiulcer class allowed

          -  No concurrent oral anticoagulation for treatment of thrombosis

               -  Concurrent warfarin (1 mg) to maintain patency of central venous catheter allowed