Clinical trial NCT00407251 (phase 2, status: completed)
Conditions: hormone refractory prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: patupilone
SMILES: [H]\C(=C(\C)[C@]1([H])C[C@]2([H])O[C@]2(C)CCC[C@]([H])(C)[C@]([H])(O)[C@@]([H])(C)C(=O)C(C)(C)[C@@]([H])(O)CC(=O)O1)C1=CSC(C)=N1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histological or cytological diagnosis of adenocarcinoma of the
             prostate.

          -  Patients must have metastatic or locally recurrent disease.

          -  Patients must have documented evidence of PSA progression

          -  The PSA must be > 5 ng/mL at the time of study entry.

          -  ECOG performance status of 0, 1 or 2.

          -  Patients must have a life expectancy of at least 12 weeks in the judgment of the
             investigator.

          -  Chemotherapy: patients must have received prior docetaxel based chemotherapy (either
             as a single agent or in combination). Patients must have evidence of progression while
             receiving docetaxel based chemotherapy or within 6 months after the completion of
             docetaxel based chemotherapy. Prior adjuvant or neoadjuvant chemotherapy is permitted
             provided therapy was completed > 12 months prior to registration. Prior therapy with
             mitoxantrone or experimental non-cytotoxic chemotherapy is permitted (e.g. monoclonal
             antibodies, vaccine therapy, receptor tyrosine kinase inhibitors).

          -  Hormonal Therapy: Prior hormone therapy is permitted. Patients must be hormone
             refractory and have been previously and currently treated with androgen ablative
             therapy (medical or surgical castration). Therapy with LHRH agonist must continue for
             those prostate cancer patients already receiving this treatment at the time of
             enrollment. If the patient has discontinued the LHRH agonist, this must be restarted
             and the castrate level of testosterone must be present. Patients must have
             discontinued any use of non-steroidal antiandrogens (e.g. bicalutamide, nilutamide,
             flutamide) at least 6 weeks prior to initiation of protocol therapy.

          -  Radiation: Prior external beam radiation is permitted provided a minimum of 4 weeks
             has elapsed between the last dose and enrollment to the trial. Exceptions may be made
             for low dose, nonmyelosuppressive radiotherapy after consultation with the principal
             investigator. Prior strontium is not permitted. Patients must have had less than 30%
             of marrow bearing areas irradiated.

          -  Steroids: Current treatment with steroids are permitted provided the dose is less than
             or equivalent to a daily dose of prednisone of 20mg.

          -  Laboratory Requirements - within 7 days prior to enrollment Hematology: absolute
             granulocytes ≥ 1.5 x 109/Lplatelets ≥ 100 x 109/Lhemoglobin ≥ 90 g/L Biochemistry:
             bilirubin ≤ 1.0 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal
             AST/ALT ≤ 2.5 x upper limit of normal

          -  Patient consent must be obtained according to local Institutional and/or University
             Human Experimentation Committee requirements.

          -  Patients must be accessible for treatment and follow-up. Patients registered on this
             trial must be treated and followed at the participating centre.

        Exclusion Criteria:

          -  Patients with a history of other invasive cancer, except adequately treated
             non-melanoma skin cancer or other solid tumours curatively treated with no evidence of
             disease for > 3 years.

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to Patupilone or other agents used in the study.

          -  Other serious intercurrent illness of medical condition that might be aggravated by
             protocol treatment including: myocardial infarction within 6 months prior to study
             entry congestive heart failure unstable angina active cardiomyopathy unstable
             ventricular arrhythmia uncontrolled hypertension uncontrolled psychotic disorders
             serious infections active peptic ulcer disease

          -  HIV-positive patients receiving combination anti-retroviral therapy

          -  Peripheral neuropathy > grade 1.

          -  Patients who have received treatment with other investigational agents or anti-cancer
             therapy < 21 days prior to date of protocol treatment.

          -  Patients receiving anticoagulation with warfarin (Coumadin®).

          -  Patients with grade ≥ 1 diarrhea.