Clinical trial NCT00556205 (phase 2, status: withdrawn)
Conditions: renal cell carcinoma
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: sunitinib, bevacizumab
SMILES: CNC(=O)C1=C(SC2=CC=C3C(NN=C3\C=C\C3=CC=CC=N3)=C2)C=CC=C1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    toxicity of combination from other trials
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed metastatic renal cell carcinoma with clear cell histology

          -  Patients must be off sunitinib for 14 days prior to day 1 of treatment on protocol

          -  Evidence of unidimensionally measurable disease based on RECIST criteria, with at
             least 1 measurable lesion

          -  Radiographic evidence of disease progression defined by RECIST during or within 6
             weeks of completion of sunitinib treatment

          -  Participants must have received at least 14 doses of sunitinib therapy

          -  Participants must enroll within 3 months of the last dose of sunitinib

          -  Males or females, age of 18 years or older

          -  ECOG Performance status 0-2

          -  Resolution of all acute toxic effects of prior therapy, radiotherapy or surgical
             procedures to NCI CTCAE version 3.0 grade 1 or less

          -  Laboratory values as defined in protocol

          -  4 weeks or more must have elapsed from the time of major surgery and subjects must
             have recovered from the procedure prior to day 1 of randomization

          -  No anticipated need for major surgical procedure during the course of the study

          -  2 weeks or more must have elapsed from the time of minor surgery and subjects must
             have recovered from the procedure prior to day 1 of randomization

          -  4 weeks of more must have elapsed from the time of major radiotherapy prior to day 1
             of randomization

        Exclusion Criteria:

          -  Prior treatment with bevacizumab

          -  Unacceptable toxicity on prior sunitinib therapy at 37.5mg or lower

          -  Prior systemic therapy for RCC with > 2 regimens

          -  Systemic therapy other than sunitinib within 4 weeks of starting the study treatment

          -  Uncontrolled high blood pressure

          -  Any prior history of hypertensive crisis or hypertensive encephalopathy

          -  History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess
             within 3 months prior to day 0

          -  Any of the following within the 6 months prior to sudy drug administration: myocardial
             infarction, severe/unstable angina, coronary/peripheral artery bypass graft,
             cerebrovascular accident or transient ischemic attack, symptomatic congestive heart
             failure, or ejection fraction < 30%

          -  Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
             the normal range without medication

          -  History of or known brain metastases or spinal cord compression

          -  NCI CTCAE grade 2 or above hemorrhage within 4 weeks of starting study treatment

          -  Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

          -  Symptomatic peripheral vascular disease

          -  Grade 3 or higher cardiac dysrhythmia or QT prolongation

          -  Concurrent use of proarrhythmic medications including terfenadine, quinidine,
             procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone,
             indapamide and flecainide

          -  Pregnancy or breastfeeding or inadequate contraception

          -  Significant thromboembolic event within 6 months

          -  Evidence of bleeding diathesis or coagulopathy

          -  Serious, non-healing wound, ulcer or bone fracture

          -  Proteinuria at screening

          -  Known hypersensitivity to any component of bevacizumab

          -  Psychiatric illness/social situation that would limit compliance with study
             requirements

          -  Previous or concurrent malignancy requiring active systemic therapy