Clinical trial NCT00556049 (phase 2, status: completed)
Conditions: renal cell carcinoma, neoplasm metastases
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: gemcitabine, sunitinib
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CNC(=O)C1=C(SC2=CC=C3C(NN=C3\C=C\C3=CC=CC=N3)=C2)C=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven metastatic renal cell carcinoma with any sarcomatoid histology
             or poor-risk features as defined by having 3 or more of the following characteristics:

               -  PS > 1, high serum lactate dehydrogenase

               -  low hemoglobin

               -  high "corrected" serum calcium

               -  2 or more sites of metastatic disease

               -  time from initial diagnosis to evidence of metastatic disease 12 months or less

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

          -  Male or female, 18 years of age or older

          -  ECOG performance status of 0-2

          -  Patients with brain metastasis can only be included of they were treated 4 weeks or
             more prior to enrollment with whole brain radiation and the effects of treatment have
             resolved

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

          -  Laboratory values as outlined in the protocol

          -  2 weeks or more must have elapsed from the time of major surgery or radiation therapy
             prior to the day of registration

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

        Exclusion Criteria:

          -  Prior treatment with sunitinib or gemcitabine

          -  More than one prior systemic therapy of any kind for renal cell carcinoma

          -  Uncontrolled high blood pressure

          -  Any prior history of hypertensive crisis or hypertensive encephalopathy

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

          -  Ejection fraction < 30%

          -  Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
             the normal range with medication

          -  NCT CTCAE grade 3 or higher hemorrhage within 4 weeks of starting treatment

          -  Significant vascular disease

          -  Current 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

          -  Evidence of bleeding diathesis or coagulopathy

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

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

          -  Previous diagnosis of concurrent malignancy requiring active systemic therapy