Clinical trial NCT00879619 (phase 1/phase 2, status: terminated)
Conditions: prostate cancer, adenocarcinoma of the prostate, recurrent prostate cancer, stage i prostate cancer, stage iii prostate cancer, stage iv prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: sunitinib malate, docetaxel, prednisone
SMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C
Reason stopped: 
    terminated due to slow accrual.
  
Eligibility criteria:

        Inclusion Criteria

          -  Subjects must have a histological diagnosis of adenocarcinoma of the prostate

          -  Age ≥ 18

          -  Subjects must have metastatic prostate cancer deemed to be unresponsive or refractory
             to hormone therapy by one or more of the following (despite androgen deprivation and
             anti-androgen withdrawal when applicable) check all that apply.

          -  Subjects may have received prior surgery. However, at least 21 days must have elapsed
             since completion of surgery and Subject must have recovered from all side effects.

          -  Subjects must have adequate hepatic function as defined by:

          -  a serum bilirubin ≤1.5 x the institutional upper limit of normal (IULN),

          -  Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase
             (SGPT) ≤2.5 x the institutional upper limit of normal obtained within 14 days prior to
             start of therapy

          -  Subjects must have 2 pre-study PSA > 2ng/ml at least 1 week apart within 28 days prior
             to start of therapy

          -  Subjects must have been surgically or medically castrated. If method of castration is
             luteinizing hormone-releasing hormone (LHRH) agonist (leuprolide or goserelin), then
             the Subject should be willing to continue the use of LHRH agonists. Castration using
             LHRH agonist should not be interrupted and subjects who have stopped treatment should
             be willing to restart.

          -  Subjects must not take vitamins, herbs, or micronutrient supplement within 28 days
             prior to start of therapy.

          -  Prior external beam radiation therapy (to less than 30% of the bone marrow only) is
             allowed. This includes prior use of samarium, but subjects can not have received prior
             strontium. At least 28 days must have elapsed since the completion of radiation
             therapy and the Subject must have recovered from side effects. Soft tissue disease
             which has been radiated in the prior 2 months is not assessable as measurable disease.

          -  Subjects with a history of myocardial infarction are not eligible. Subjects must have
             a baseline EKG to rule out underlying cardiac disease within 42 days prior to
             registration. Subjects with a history of cardiac disease, specifically congestive
             heart failure (CHF) are ineligible unless their disease is well-controlled. Subjects
             with history of cardiovascular accident (CVA) or atrial fibrillation are ineligible.

          -  Subjects with a history of brain metastases or who currently have treated or untreated
             brain metastases are not eligible. Subjects with clinical evidence of brain metastases
             must have a brain CT or MRI negative for metastatic disease within 56 days prior to
             registration.

             *Liver function tests should be evaluated prior to each treatment.

          -  Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status
             0-2.

          -  Subjects must have an adequate renal function as defined by:

          -  a serum creatinine ≤1.5 x the institutional upper limit of normal obtained within 14
             days prior to start of therapy and a urine protein: creatinine (UPC) ratio of ≤ 1.0.

          -  Subjects must have the following hematological criteria (minimal values):

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Hemoglobin of ≥ 8.0gm/dL,

          -  White blood cell count ≥ 2500,

          -  Platelets ≥ 75,000/mm³

          -  Subjects must be able to take oral medications

        Exclusion Criteria

          -  Subjects must not have received chemotherapy, biologic therapy or any other
             investigational drug for any reason within 28 days prior to start of therapy and must
             have recovered from toxicities of prior therapy to grade 1 or less with the exception
             of alopecia.

          -  Subjects may not have ongoing problems with bowel obstruction or short bowel syndrome
             characterized by grade 2 or greater diarrhea or malabsorptive disorders.

          -  Men of child bearing potential must be willing to consent to using effective
             contraception while on treatment and for at least 3 months thereafter.

          -  Subjects with a history of severe hypersensitivity reaction to docetaxel or other
             drugs formulated with polysorbate 80 will be excluded

          -  Subjects should not have psychological, familial, sociological, or geographical
             conditions that do not permit medical follow-up or compliance with the study protocol.

          -  Subjects should not have any medical life-threatening complications of their
             malignancies

          -  Subjects should not have a known severe and/or uncontrolled concurrent medical disease
             (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active
             uncontrolled infection, or HIV).

          -  Subjects should not have current, recent (within 4 weeks of the first infusion of this
             study), or planned participation in an experimental drug study.

          -  Baseline blood pressure of < or equal to 150/100 mmHg. Subjects with a blood pressure
             reading above this level should be initiated on anti-hypertensive therapy and may be
             considered for protocol treatment when their blood pressure is adequately controlled.

          -  Subjects with New York Heart Association (NYHA) Grade II or greater congestive heart
             failure are not eligible. Subjects must have a baseline multiple gated acquisition
             scan (MUGA) or Echocardiogram with a calculated ejection fraction > or equal to 50%.

          -  Subjects with clinically significant peripheral vascular disease are not eligible.

          -  Subjects with evidence of bleeding diathesis or coagulopathy are not eligible.

          -  Subjects with central nervous system or brain metastases are not eligible.

          -  Subjects who had major surgical procedure, open biopsy, or significant traumatic
             injury within 28 days prior to Day 0, anticipation of need for major surgical
             procedure during the course of the study are not eligible.

          -  Subjects with minor surgical procedures, fine needle aspirations or core biopsies
             within 7 days prior to Day 0 are not eligible.

          -  Subjects with history of abdominal fistula, gastrointestinal perforation, or
             intra-abdominal abscess are not eligible.

          -  Subjects with serious, non-healing wound, ulcer, or bone fracture are not eligible.

          -  Subjects who are diagnosed of any other malignancy except non-melanomatous skin cancer
             in the past 5 years are not eligible.

          -  Subjects receiving anticoagulation therapy (e.g. Coumadin) prior to registration are
             not eligible. Subjects are permitted to have prior Coumadin for prophylaxis against
             agents that might produce blood clots. Subjects with low dose Aspirin (86mg) are
             acceptable.

          -  Subjects with active thrombophlebitis or hypercoagulability are not eligible. Subjects
             with known history of pulmonary embolus are not eligible.

          -  All Subjects must be informed and must sign and give written informed consent in
             accordance with institutional and federal guidelines. Subjects who are unable to
             comply with study and/or follow-up procedures are not eligible.