Clinical trial NCT00521781 (phase 2, status: terminated)
Conditions: prostatic neoplasms
ICD codes: B38.81, N42.31, Z87.430, N40.0, N40.1
Drugs: abraxane, leuprolide, bicalutamide
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C, CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O, [H][C@]12SCC(C)=C(N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=C(O)C=C1)C(O)=O
Reason stopped: 
    sponsor decision
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologic proof of adenocarcinoma of the prostate.

          -  Patients must belong to one of four groups: 1) Local/Regional with prior definitive
             therapy: Patients with local/regional recurrence following prostatectomy or radiation
             therapy who still have a normal bone scan. 2) Local/Regional without prior definitive
             therapy: Patients felt to be unresectable, or are felt not to be candidates for,
             radiation therapy. 3) Low volume bone disease: Patients with 1 or 2 bone metastases.
             4) High volume bone/visceral disease: Patients with ≥ 3 metastatic bone sites or
             visceral metastases.

          -  Patients meeting these criteria are eligible even without any radiographically
             demonstrable abnormality. All patients must have an elevated PSA prior to initial
             hormone exposure defined as: 1) For patients with prior prostatectomy, the PSA must be
             rising with an associated doubling time of ≤ 3 months. 2) For patients with prior
             radiation therapy, the PSA must be ≥ 1.0 ng/mL with an associated doubling time of ≤ 3
             months. 3) For patients with the prostate in place, the PSA must be elevated with
             biopsy proven disease and are not candidates for local therapy.

          -  Patients may be on an LHRH agonist (with or without an anti-androgen), or already
             medically castrated, at the time of study entry, provided such therapy was started
             within 3 months of study entry.

          -  No previous cytotoxic systemic therapy of any kind is allowed, including systemic
             irradiation with strontium-89 and samarium. Previous definitive radiotherapy to one
             metastatic site is acceptable. At least 8 weeks must have elapsed since radiation
             therapy to the pelvis. Patients having limited irradiation of a single metastatic site
             are eligible 4 weeks following the completion of radiation.

          -  Patients may have had previous exposure to androgen deprivation therapy if it was
             given for ≤ 6 months to, "downstage" the primary, and provided such therapy completed
             at least 12 months prior to entry into this study.

          -  Patients must be free of serious co-morbidity and have a life expectancy of ≥ 3 years.

          -  Patients must have adequate physiologic reserves as evidenced by Zubrod Performance
             Status (ZPS) of ≤ 2, adequate bone marrow function, renal function and liver function
             and no evidence of active ischemia on ECG (if clinically indicated, documentation of
             EF ≥ 40%.)

        Exclusion Criteria:

          -  Patients must not have a second malignancy unless there is confidence of previous
             curative therapy.

          -  Patients with a recent history of TIA (within 6 months), or are requiring regular
             antianginal therapy or are having claudication sufficient to limit activity are not
             eligible. Patients with a previous history of deep venous thrombosis or pulmonary
             embolism (within 12 months) are not eligible.

          -  Patients must not have a serious intercurrent medical or psychiatric illness,
             including serious active infection.

          -  Patients must not have Sensory neuropathy of grade 1 or greater.