Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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)
Countries
United States