Zoledronate and BMS-275291 in Treating Patients With Prostate Cancer
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

About this trial
This is an interventional treatment trial for Adenocarcinoma of the Prostate
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (rebimastat, zoledronic acid)
Arm II (zoledronic acid)
Patients receive zoledronate IV over at least 15 minutes on day 1 and oral BMS-275291 daily on days 1-28.
Patients receive zoledronate as in Arm I.