Clinical trial NCT00471718 (phase 1/phase 2, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: abt-751
SMILES: COC1=CC=C(C=C1)S(=O)(=O)NC1=C(NC2=CC=C(O)C=C2)N=CC=C1
Reason stopped: 
    pharmaceutical company closed study because the treatment was not effective
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years of age.

          -  Patients must have histologically proven adenocarcinoma of the prostate gland.

          -  Patients must have metastatic disease (e.g. bone metastases, pelvic mass, nodal, liver
             or lung metastases), with evidence of radiographic progression (including bone scans
             observed during last treatment) or serologically -Patients with bone-only metastases
             (i.e. lacking soft tissue or visceral disease) must have a PSA level > 10 ng/mls.
             Patients with soft tissue metastases and/or visceral disease must have either
             measurable disease OR a PSA level > 10 ng/ml.

          -  Patients must have had prior treatment with bilateral orchiectomy or other primary
             hormonal therapy (e.g. LHRH therapy, estrogens, etc.) with evidence of treatment
             failure and simultaneous documentation of a castrate testosterone level (< 50 ng/dL)
             NOTE: Patients who have not undergone bilateral orchiectomy must continue LHRH agonist
             therapy for the duration of this protocol unless this medically contraindicated.

          -  For patients previously treated with flutamide, nilutamide, or bicalutamide: patients
             must have discontinued flutamide or nilutamide > 4 weeks prior to randomization (> 6
             weeks for bicalutamide) with no evidence of an anti-androgen withdrawal response (i.e.
             no decline in serum PSA and/or no improvement in baseline scans).

          -  Patients must have received prior therapy with docetaxel alone or in combination with
             either prednisone or estramustine. This therapy may have been given in a neoadjuvant,
             adjuvant or metastatic setting

          -  Patients must not have received radiotherapy < 3 weeks prior to randomization. If
             patients have received prior radiotherapy to an evaluable lesion(s), there must be
             evidence of radiographic progression prior to entry.

          -  Patients must not have received prior Strontium 89, Samarium 153, or other therapeutic
             radioisotopes.

          -  Patients must have recovered from all systemic toxicities due to prior treatment for
             prostate cancer (does not include incontinence, impotence, etc. secondary to primary
             therapy)

          -  The patient must have an ECOG Performance Status of 0-1

          -  The patient must have adequate hematologic, renal and hepatic function as follows:

               1. Hematologic: ANC > 1200/mm3; hemoglobin > 9.0 g/dl; platelets > 100,000/mm3

               2. Renal: serum creatinine < 2.0 mg/dL

               3. Hepatic: bilirubin < 2.5 mg/dL; AST and ALT < 2.5X upper limit of normal (ULN); <
                  5X ULN for patients with hepatic metastases

          -  Sexually-active patients must use a contraceptive method deemed acceptable by the
             investigator while in the study and for up to 3 months following completion of
             therapy.

          -  The patient or the patient's legally acceptable representative has voluntarily signed
             and dated an informed consent approved by and Institutional Review Board prior to any
             study any study specific procedures.

          -  Patients may be receiving bisphosphonate therapy prior to randomization and continue
             while receiving protocol therapy, but must not begin treatment with bispohosphonates
             while receiving protocol therapy. Patients on bisphosphonates must have completed at
             least 4 weeks of bisphosphonate therapy prior to entry onto study.

          -  Patients with a history of a prior malignancy are eligible provided they were treated
             with curative intent and have been free of disease for the time period considered
             appropriate for the specific malignancy.

        Exclusion Criteria:

          -  No active angina pectoris, uncontrolled hypertension, or known heart disease of New
             York Heart Association Class III-IV. Patients must not have a history of myocardial
             infarction, congestive cardiac failure (New York Heart Association Class 3), or
             coronary angioplasty/stenting < 6 months prior to entry.

          -  No carcinomatous meningitis or brain metastases.

          -  Any investigational therapy within 4 weeks.

          -  No serious concurrent medical illness or active infection, which, in the opinion of
             the investigator, would jeopardize the ability of the patient to receive the
             chemotherapy outlined in this protocol with reasonable safety.

          -  Documented history of allergy to sulfa medications.

          -  Current colchicines treatment

          -  Greater than Grade 1 CTC neurology category findings (Appendix A).

          -  Prior treatment with more than 1 prior chemotherapy regimen.