Clinical trial NCT00426829 (phase 1, status: terminated)
Conditions: liver cancer, hepatocellular carcinoma, cholangiocarcinoma
ICD codes: D13.4, Z85.05, C22.8, C78.7, C22.9, D37.6, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: bevacizumab
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    low accural
  
Eligibility criteria:

        Inclusion Criteria:

          -  Cytologic or histologic proof of primary liver cancer (hepatocellular carcinoma or
             cholangiocarcinoma). Patients with non-metastatic, unresectable disease are eligible.
             Patients with positive margins after surgical resection are eligible. Metastasis is
             defined as unequivocal evidence of extrahepatic disease based on CT imaging, excluding
             nodal disease.

          -  Tumors must not be greater than 10cm (small satellite lesions around a larger lesion
             are allowed), all of which can be encompassed in a radiation treatment field (as
             assessed by the radiation oncologist).

          -  Prior chemotherapy, transarterial chemoembolization and radiofrequency ablation are
             permitted. A minimum of four weeks must have elapsed between prior treatment and
             planned protocol therapy.

          -  Prior liver resection is permitted as long as the interval between surgery and
             enrollment is at least 4 weeks.

          -  Karnofsky performance status >/= 70 are eligible.

          -  There is no age restriction.

          -  Absolute granulocyte count >/= 1,500 cells/mm3, hemoglobin >/= 8 gm/dL and platelet
             count >/= 80,000 cells/mm3.

          -  Serum creatinine </= 1.5 mg/dl.

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </= 3 times the
             upper limit of normal. Serum bilirubin </= 5mg/dL prior to the start of therapy.

          -  A signed study-specific consent form, which is attached to this protocol.

        Exclusion Criteria:

          -  Child-Pugh class C cirrhosis.

          -  Gross ascites seen on CT that precludes accurate targeting of the tumor with radiation
             therapy

          -  Proteinuria at screening as demonstrated by either Urine protein:creatinine (UPC)
             ratio > 1.0 at screening OR Urine dipstick for proteinuria > 2+ (patients discovered
             to have > 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour
             urine collection and must demonstrate < 1g of protein in 24 hours to be eligible).

          -  Patients currently receiving anticoagulation treatment with coumadin, low molecular
             weight heparin or IV heparin. Evidence of bleeding diathesis or coagulopathy.
             Anticoagulation for line maintenance is permitted.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0, or anticipation of need for major surgical procedure during the course
             of the study; fine needle aspirations or core biopsies within 7 days prior to Day 0.

          -  Serious, nonhealing wound, ulcer, or bone fracture.

          -  Clinically significant cardiac disease (e.g., uncontrolled hypertension [blood
             pressure of >150/100 mmHg on medication], history of myocardial infarction within 6
             months, unstable angina), New York Heart Association (NYHA) Class II or greater
             congestive heart failure, unstable symptomatic arrhythmia requiring medication
             (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal
             supraventricular tachycardia are eligible), or Class II or greater peripheral vascular
             disease.

          -  History of aneurysms, strokes, transient ischemic attacks, and arteriovenous
             malformations within 6 months.

          -  Prior unanticipated severe reaction to bevacizumab.

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to Day 0

          -  Patients who have had an organ allograft.

          -  Pregnant women are excluded from this study; women of childbearing potential must
             agree to practice adequate contraception (oral, injectable, or implantable hormonal
             contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with
             spermicide; or vasectomized partner) and to refrain from breast feeding, as specified
             in the informed consent. Women of child-bearing potential are defined as those women
             who have not had surgical sterilization or been menopausal for 12 consecutive months.

          -  Male patients must agree not to father a child and must agree to use a condom.

          -  Prior radiation therapy to an upper abdominal or lower thoracic field that could
             overlap with the proposed treatment field.

          -  Serious concomitant medical or psychiatric disorders that place the patient at high
             risk for non-compliance with or morbidity due to protocol therapy.

          -  Patients with a history of hypertension must be well-controlled (</= 140/90 mmHg on a
             stable regimen of antihypertensive therapy)