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

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)