SB-715992 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Docetaxel or Paclitaxel
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

About this trial
This is an interventional treatment trial for Adenocarcinoma of the Prostate
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
Sites / Locations
- Southwest Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (ispinesib)
Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.