BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients With Hormone Refractory Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: ixabepilone


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ixabepilone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer