Clinical trial NCT00394810 (phase 2, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: panzem® ncd
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C(OC)=C3
Eligibility criteria:

        Inclusion Criteria:

          1. Patients (pts) must have histologically or cytologically confirmed adenocarcinoma of
             the prostate.

          2. Pts must have evidence of progressive metastatic disease (e.g., new lesions on bone
             scan or new/enlarging lesions on computerized tomography [CT] scan) or known
             metastatic disease and rising PSA, during or after treatment with a taxane-based
             regimen (as well as any other subsequent non-cytotoxic therapy).

               -  Pts with bone metastases only (i.e., lacking soft-tissue disease) must have a PSA
                  level of 10 ng/mL or higher.

               -  Pts with soft tissue metastases and/or visceral disease must have either
                  measurable disease (per RECIST criteria) or a PSA level of 10 ng/mL or higher.

               -  For pts with stable metastatic disease and rising PSA: two consecutive rises in
                  PSA measurement are necessary, each separated from the previous by a minimum of
                  two weeks. The most recent PSA value must be obtained within 1 week prior to
                  registration.

               -  At least 3 PSA values within 6 months of registration (each separated by at least
                  2 weeks) using the same clinical laboratory needs to be available for calculation
                  of the PSA pre-treatment slope. Only those values obtained after the last
                  treatment date (see inclusion criteria #5 below) will be acceptable.

          3. Pts must have had prior treatment with bilateral orchiectomy or other primary hormonal
             therapy with evidence of treatment failure.

               -  Pts who have not undergone bilateral orchiectomy must continue their luteinizing
                  hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide or goserelin)
                  or LHRH antagonist (e.g. abarelix) while receiving protocol therapy.

               -  A serum testosterone level of 50 ng/dL or lower is required to confirm castration
                  status within 4 weeks prior to study entry.

          4. For pts previously treated with flutamide (Eulixin), Nilutamide (Nilandron), or
             bicalutamide (Casodex): pts must have discontinued flutamide 4 weeks or more prior to
             registration with continued evidence of progressive disease. For bicalutamide or
             nilutamide, pts must have discontinued the drug 6 weeks or more prior to registration
             with evidence of progressive disease.

             • Disease progression following anti-androgen withdrawal needs to be confirmed by a
             rising PSA after the required 4-6 week washout period (e.g. PSA level higher than the
             last PSA obtained while on anti-androgen therapy).

          5. Pts must have received only one prior taxane-based regimen for metastatic disease,
             with evidence of disease progression (inclusion criteria #2) during treatment or
             within 6 months of treatment discontinuation. Up to one other prior experimental
             therapy (non-cytotoxic) is permitted. At least 4 weeks or more from previous treatment
             must have elapsed prior to registration, with evidence for disease progression as
             outlined in inclusion criteria #2.

          6. Age ≥18 years.

          7. Life expectancy of greater than 12 weeks.

          8. Eastern Cooperative Oncology Group [ECOG] performance status of 2 or less

          9. Pts must have near normal organ and marrow function within 2 weeks prior to
             registration as defined below:

               -  Granulocytes > 1500/mm³

               -  Platelet count > 100,000/mm³

               -  Bilirubin < 1.5 mg/dL

               -  Serum glutamate pyruvate transaminase (ALT) < 2 times the institutional upper
                  limit of normal

               -  Creatinine < 1.5 mg/dL or a calculated creatinine clearance > 50 mL/min

         10. Pts with a history of prior malignancy are eligible provided they were treated with
             curative intent and have been free of disease for 5 years or more (excluding
             non-melanomatous skin cancers treated with curative intent).

         11. All sites of disease must be evaluated within 4 weeks prior to registration.

         12. Have the ability to understand the requirements of the study, provide written informed
             consent and authorization for release of protected health information, abide by the
             study restrictions, and agree to return for the required assessments.

        Exclusion Criteria:

          1. The use of bisphosphonates (i.e. pamidronate sodium or zoledronic acid) will be
             allowed provided that the patient has been receiving that medication for 4 weeks or
             more with evidence of progressive disease as outlined above.

             • Pts will not be allowed to start bisphosphonate while receiving protocol treatment
             unless clinically indicated (will need approval of the study principal investigator).
             Those patients already on a bisphosphonate will need to continue to receive the
             bisphosphonate as previously scheduled.

          2. Pts must not have had prior radiotherapy within 4 weeks prior to registration. Patient
             cannot have had prior Strontium 89, Samarium 153, or other radioisotope.

             • If a pt requires palliative radiotherapy, two consecutive rises (baseline value must
             be obtained after completion of radiation treatment) in PSA measurement are necessary,
             each separated from the previous by a minimum of two weeks.

          3. No concurrent use of estrogen, or estrogen-like agents (i.e. PC-SPES, Saw Palmetto, or
             other herbal products which may contain phytoestrogens), or any other hormonal therapy
             (including megastrol acetate, finasteride, ketoconazole, and systemic corticosteroids)
             is allowed at any time during the study. Prior use of these agents will need to be
             discontinued 4 weeks or more prior to enrollment. Disease progression needs to be
             confirmed as outlined in inclusion criteria #2.

          4. Pts with type I insulin-dependent diabetes or poorly-controlled type II
             insulin-dependent diabetes or a fasting blood glucose of more than 10 mmol/L (200
             mg/dL) will be excluded due to difficulty evaluating the tumor metabolic activity
             using FDG-PET.

          5. Patients must not have active angina pectoris, or known heart disease of New York
             Heart Association Class III-IV. Patients must not have a history of myocardial
             infarction within 6 months prior to registration. No history or evidence of
             ventricular dysrhythmias or other unstable arrythmia is allowed (rate controlled
             atrial fibrillation is allowed if the patient is asymptomatic from a cardiac
             standpoint).

          6. Patients must not have any known history of carcinomatous meningitis or brain
             metastases.

          7. No serious concurrent medical illness or active infection should be present which
             would jeopardize the ability of the patient to receive the therapy outlined in this
             protocol with reasonable safety.

          8. No major surgery within 21 days of starting treatment with Panzem NCD.

          9. Pts must not receive any investigational agents other than Panzem NCD for the duration
             of their participation in this trial.