Zoledronate and BMS-275291 in Treating Patients With Prostate Cancer

Inclusion Criteria:

Histologically or cytologically confirmed (adeno)carcinoma of the prostate refractory to hormone therapy

Metastatic bone disease, as documented by bone scan and confirmed by x-rays, CT scan or MRI scan

Note: Patients may also have measurable disease in the lymph nodes (retroperitoneal, pelvic or inguinal only), prostate and /or prostatic bed; measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm =< 21 days prior to registration
PSA progression defined as two consecutive increases in PSA value over the previous reference value; the first increase of PSA should occur no earlier than one (1) week after the reference measurement; all patients need to demonstrate continued PSA elevation with an increasing PSA four weeks after the required cessation of their antiandrogen treatment; the required cessation period is 4 weeks for flutamide, nilutamide, and Megace-based treatment, and 8 weeks for bicalutamide-based treatment

One of the following:

Continuing primary androgen suppression (LHRH agonist)
Orchiectomy
WBC >= 2000/mm^3
Absolute neutrophil count (ANC) >= 1500/mm^3
PLT >= 100,000/mm^3
Hgb >= 9.0 g/dL
Total bilirubin =< institutional upper normal limits (UNL)
AST =< 1.5 x UNL
Serum creatinine =< 1.5 x UNL
PSA >= 5 ng/mL
Serum testosterone < 50 ng/dL =< 3 months prior to registration
Estimated life expectancy of >= 6 months
ECOG Performance Status (PS) 0, 1, or 2
Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent
If sexually active, willing to use an accepted and effective method of contraception consistently for the duration of study participation

Exclusion Criteria:

Any of the following:

> 2 prior chemotherapy regimen
> 2 non-hormonal treatments for metastatic disease (including biologics, gene therapy, angiogenesis inhibitors, etc., but excluding external radiotherapy)
Prior therapy with a matrix metalloproteinase inhibitor (MMPI)
Immunotherapy =< 4 weeks prior to study entry
Biologic therapy =< 4 weeks prior to study entry
Radiation therapy =< 4 weeks prior to study entry
Concomitant hormonal treatment (except LHRH)
Prior use of systemic radiopharmaceuticals such as samarium and strontium
PC-Spes =< 4 weeks prior to study entry
Failure to fully recover from adverse effects of prior therapies regardless of interval since last treatment
Other concurrent chemotherapy, immunotherapy, or radiotherapy directed at the cancer
Other therapy or supportive care that is considered investigational
Known CNS metastases
Known visceral metastases (pulmonary, liver, kidney, splenic lesions); patients with retroperitoneal, pelvic or inguinal lymph node metastases and/or disease in the prostate (or prostatic bed) will not be excluded

Uncontrolled intercurrent illness including, but not limited to:

Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris, cardiac arrhythmia
Psychiatric illness/social situations that would limit compliance with study requirements
HIV-positive patients receiving combination anti-retroviral therapy
Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancer from which the patient has been disease free for >= 5 years