bms-247550 in treating patients with prostate cancer that has not responded to hormone therapy

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of bms-247550 in treating patients who have prostate cancer that has not responded to hormone therapy.

objectives: * determine the prostate-specific antigen response to bms-247550 in patients with hormone-refractory prostate cancer. * determine the overall survival and progression-free survival rate in patients treated with this drug. * determine the objective response rate (confirmed and unconfirmed complete and partial responses) in those patients with measurable disease treated with this drug. * evaluate the qualitative and quantitative toxic effects of this regimen in these patients. outline: this is a multicenter study. patients receive bms-247550 iv over 3 hours on day 1. treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. patients achieving a complete response (cr) receive 2 additional courses beyond cr. patients are followed every 3 months for 1 year and then every 6 months for 2 years. projected accrual: a total of 25-45 patients will be accrued for this study within 5-9 months.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate * stage d1 or d2 disease (t4, n0, m0; any t, n1-3, m0; or any t, any n, m1) * unresponsive or refractory to prior hormonal therapy by at least 1 of the following: * progression of unidimensionally measurable lesion outside of a prior radiation port * progression of non-measurable disease (e.g., bone scan) * rising prostate-specific antigen (psa) on at least 2 consecutive measurements taken at least 7 days apart * psa at least 5 ng/ml * no brain metastases patient characteristics: age: * not specified performance status: * zubrod 0-2 life expectancy: * not specified hematopoietic: * absolute granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than upper limit of normal (uln) * sgot or sgpt no greater than 2.5 times uln renal: * creatinine no greater than 2.0 mg/dl or * creatinine clearance at least 40 ml/min other: * no other malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, any carcinoma in situ, or stage i or ii cancer in complete remission * no other concurrent significant active illness that would preclude study participation * recovered from major infections * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * at least 28 days since prior biologic therapy and recovered * no more than 1 prior biologic (non-cytotoxic) therapy * no concurrent biological response modifiers chemotherapy: * no prior chemotherapy for this disease * no other concurrent chemotherapy endocrine therapy: * see disease characteristics * at least 28 days since prior flutamide or ketoconazole * at least 42 days since prior bicalutamide or nilutamide * no concurrent hormonal therapy, except luteinizing hormone-releasing hormone therapy * no concurrent corticosteroids radiotherapy: * see disease characteristics * prior radiotherapy to less than 30% of bone marrow allowed * no prior strontium chloride sr 89 or samarium sm 153 lexidronam pentasodium * at least 28 days since prior radiotherapy and recovered * no concurrent radiotherapy surgery: * recovered from prior surgery * prior orchiectomy allowed other: * no concurrent unconventional therapy (e.g., st. john's wort, pc-spes, or other herbal remedy for prostate cancer) * not planning to begin bisphosphonate therapy (patients already receiving bisphosphonates are eligible provided they have progressive disease)

Keywords: adenocarcinoma of the prostate stage iv prostate cancer recurrent prostate cancer