Clinical trial NCT01194960 (phase 2, status: terminated)
Conditions: hormone refractory prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: docetaxel, trovax
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        INCLUSION CRITERIA:

          1. Signed & dated written informed consent obtained from subject in accordance w/local
             regulations.

          2. Histologically confirmed conventional and/or mucinous adenocarcinoma of the prostate.
             If histological confirmation is not available, cytological confirmation will be
             permitted in lieu.

          3. Must meet one of following 3 criteria for progressive disease following androgen
             deprivation:

        A. Subjects w/nodal or visceral metastases:

        Must have progressive disease defined by RECIST criteria or defined by the Prostate Cancer
        Clinical Trials Working Group II (Scher et al. 2008).

        B. Subjects w/no measurable disease:

        PSA only disease must have an elevated PSA as defined by Consensus Criteria Prostate Cancer
        Clinical Trials Working Group II (Scher et al. 2008). PSA must indicate progressive disease
        defined as rising PSA values, at least 7 days apart, >2 ng/mL in the 28 days prior to
        randomization.

        C. Subjects w/bone involvement:

        New disease on bone scan as defined by Consensus Criteria Prostate Cancer Clinical Trials
        Working Group II (Scher et al. 2008). 4. Subjects on stable dose of bisphosphonates showing
        subsequent tumor progression may continue on this medication; however, subjects are not
        allowed to initiate bisphosphonate therapy w/in 28 days prior to starting study treatment
        at Week 1 or at any time after that during the study, 5. Must be clinically
        immunocompetent. Clinical immunocompetence assumed unless subject has been diagnosed as
        immunosuppressed, is receiving immunosuppressive chemotherapy for oncology disorders, or is
        receiving immunosuppressive therapy following transplant, in which case they will be
        excluded.

        6. Subject free of clinically apparent/active autoimmune disease (no prior confirmed
        diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis,
        Grave's Disease, Hashimoto's Thyroiditis, Multiple Sclerosis, & Rheumatoid Arthritis).

        7. Subject has adequate bone marrow function defined by Absolute Lymphocyte Count (ALC) ≥
        500/µL, Absolute Neutrophil Count (ANC) >1200/µL, Platelet Count >100,000/µL.

        8. Subject has peripheral neuropathy grade ≤1. 9. Subject has ECOG status of 0 or 1. 10.
        Minimum life expectancy ≥6 months. 11. Progressive disease (as defined above) must be
        documented after discontinuation of the hormonal and anti-androgen therapy.

        12. Subject continues to stay on medical treatment such as LHRH agonists or LHRH
        antagonists to maintain testosterone value of <50ng/dL.

        EXCLUSION CRITERIA:

          1. Subject has received prior chemotherapy for prostate cancer at any time. Subject has
             received chemotherapy for any other reason within five years of screening.

          2. Subject is receiving any other hormonal therapy, including any dose of Megestrol
             Acetate, Finasteride, any herbal product known to decrease PSA levels (e.g., Saw
             Palmetto & PC-SPES), or any systemic corticosteroid must discontinue agent for at
             least 4 weeks prior to the anticipated Week 1 visit. LHRH agonists or LHRH antagonists
             do not need to be discontinued.

          3. Subject has started bisphosphonate or denosumab therapy less than 28 days before the
             anticipated Week 1 visit.

          4. Subject is using supplements or complementary medicines/botanicals. Subjects should
             review label w/their doctor prior to enrolment. Exceptions to this exclusion:

               -  Conventional multivitamin supplements

               -  Selenium

               -  Lycopene

               -  Soy supplements

               -  Vitamin E

               -  Fish oil supplements

               -  Vitamin D

               -  Glucosamine supplements

               -  Age-related eye disease vitamins

               -  Ginkgo biloba

          5. Subject has had major surgery or radiation therapy completed <4 weeks prior to
             screening.

          6. Corticosteroids are not permitted except for (a) nasal sprays and inhalers, (b) orally
             prescribed as replacement therapy in the case of adrenal insufficiency, (c) oral or IV
             dexamethasone administration used acutely in combination with docetaxel, (d)
             parenteral use on a single occasion, (e) low dose parenteral use for a maximum of 5
             days and (f) acute and sporadic parenteral use for acute asthma.

          7. Subject is known to test positive for HIV or hepatitis B or C.

          8. Subject receiving concurrent chemotherapy, immunotherapy, radiotherapy or
             investigational agents.

          9. Subject has Platelet count >400,000/μL; Monocytes >80,000/μL; Haemoglobin <11g/dL.

         10. Subject has cerebral metastases (known from previous investigations or clinically
             detectable).

         11. Subject has serum testosterone >50ng/dL.

         12. Subject has rheumatoid disease (asymptomatic subjects w/controlled & rarely flaring
             rheumatoid arthritis are also excluded).

         13. Subject exhibits evidence of symptomatic congestive heart failure, pulmonary embolus,
             vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable
             angina, myocardial infarction or active ischemia on ECG. If an ECG taken prior to
             screening but within 28 days of the anticipated Week 1 visit is not available, an ECG
             must be performed at screening.

         14. Subject has uncontrolled severe hypertension >150/100mm Hg (if controlled w/medication
             this is not an exclusion).

         15. Subject is hypotensive.