Clinical trial NCT00096499 (phase 2, status: completed)
Conditions: adenocarcinoma of the prostate, recurrent prostate cancer, stage iv prostate cancer
ICD codes: 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
Drugs: ispinesib
SMILES: CC(C)[C@@H](N(CCCN)C(=O)C1=CC=C(C)C=C1)C1=NC2=CC(Cl)=CC=C2C(=O)N1CC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the prostate

               -  Metastatic disease (N1 and/or M1)

               -  Unresponsive or refractory to androgen-deprivation therapy

          -  Must have received one, and only one, prior taxane-containing (docetaxel or
             paclitaxel) chemotherapy regimen for metastatic disease that was discontinued due to
             disease progression, intolerance, or patient request

          -  Evidence of disease progression as defined by ≥ 1 of the following:

               -  Progression of measurable disease

               -  Progression of evaluable disease

               -  Rising prostate-specific antigen (PSA)

                    -  At least 2 consecutive rises in PSA levels, each taken ≥ 7 days apart

                    -  PSA ≥ 5 ng/mL

          -  Must have pre-study PSA > 5 ng/mL

          -  Measurable or evaluable disease

               -  Soft tissue disease that has been irradiated within the past 2 months is not
                  considered measurable disease

               -  Soft tissue disease that has been irradiated ≥ 2 months prior to study entry is
                  considered measurable disease provided the lesion progressed after radiation

          -  Surgical or medical castration required

               -  If luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or
                  goserelin) or LHRH antagonists (abarelix) were used, then must continue use
                  during study therapy

          -  No prior or concurrent brain metastases (treated or untreated)

               -  If clinical suspicion of brain metastases, must meet the following criteria:

                    -  Brain CT scan or MRI negative for metastatic disease within the past 56 days

                    -  No new symptoms since radiographic evaluation

          -  Performance status - Zubrod 0-2

          -  Absolute granulocyte count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL

          -  Bilirubin normal

          -  SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)

          -  Creatinine ≤ 1.5 times ULN

          -  Creatinine clearance ≥ 40 mL/min

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  Fertile patients must use effective contraception

          -  No peripheral neuropathy ≥ grade 2

          -  No prior allergic reaction attributed to compounds of similar chemical or biological
             composition to SB-715992

          -  No ongoing or active infection

          -  No psychiatric illness or social situation that would preclude study participation

          -  No other uncontrolled illness

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or adequately treated stage I or II cancer in complete
             remission

          -  No colony-stimulating factors during the first course of study therapy

          -  No concurrent anticancer biologic therapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior chemotherapy and recovered

          -  See Disease Characteristics

          -  At least 4 weeks since prior flutamide or ketoconazole

          -  At least 6 weeks since prior bicalutamide or nilutamide

          -  No concurrent anticancer hormonal therapy except LHRH agonist or antagonist for
             patients who have not undergone orchiectomy

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy and recovered

          -  Prior samarium Sm 153 lexidronam pentasodium allowed

          -  No prior strontium chloride Sr 89

          -  No prior radiotherapy to ≥ 30% of bone marrow

          -  No concurrent anticancer radiotherapy

          -  See Disease Characteristics

          -  At least 3 weeks since prior surgery and recovered

          -  At least 2 weeks since prior and no concurrent use of any of the following CYP3A4
             inhibitors or inducers:

               -  Clarithromycin

               -  Erythromycin

               -  Troleandomycin

               -  Rifampin

               -  Rifabutin

               -  Rifapentine

               -  Itraconazole

               -  Ketoconazole

               -  Fluconazole (dose > 200 mg/day)

               -  Voriconazole

               -  Nefazodone

               -  Fluvoxamine

               -  Verapamil

               -  Diltiazem

               -  Grapefruit juice

               -  Bitter orange

               -  Phenytoin

               -  Carbamazepine

               -  Phenobarbital

               -  Oxcarbazepine

               -  Hypericum perforatum (St. John's wort)

               -  Modafinil

          -  At least 6 months since prior and no concurrent amiodarone

          -  No other investigational drugs for 4 weeks before, during, and for 2 weeks after study
             therapy

          -  No other concurrent anticancer cytotoxic therapy

          -  No other concurrent anticancer therapy

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  Concurrent enrollment on SWOG-9205 (central prostate cancer serum repository protocol)
             allowed