Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed prior localized adenocarcinoma of the prostate that has undergone definitive radiation or surgery and demonstrates progression biochemically with all of the following:
• •* Baseline PSA at least 4 ng/mL
• •* At least a 50% increase in PSA over at least 3 determinations taken at more than 2 week intervals
• •* No radiographically evident disease
• •* Neoadjuvant hormonal therapy prior to radical prostatectomy or radiotherapy allowed
• •* Treatment in an intermittent approach allowed if off therapy for at least 12 weeks OR
• •Histologically confirmed androgen-independent adenocarcinoma of the prostate with all of the following:
• •* Progression on primary hormonal treatment (e.g., orchiectomy, estrogen therapy, gonadotropin-releasing hormone analog with or without an antiandrogen) with either new osseous lesions in bone, a greater than 25% increase in bidimensionally measurable tumor mass, or rising PSA values (rising PSA on any 3 determinations taken at at least weekly intervals, to greater than 50% above baseline PSA) despite castrate levels of testosterone (no greater than 30 ng/mL)
• •* If receiving antiandrogen as part of primary hormonal therapy, must meet criteria above for progression after discontinuation of antiandrogen
• •* No change in hormonal therapy (including prednisone or dexamethasone) within the past 2 weeks
• •* If no prior surgical orchiectomy, must continue on medical therapies to maintain castrate levels of testosterone
• •* Prior chemotherapy, palliative radiotherapy, or radioisotope treatment allowed
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •Karnofsky 70-100%
• •Life expectancy:
• •At least 3 months
• •Hematopoietic:
• •WBC at least 3,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic:
• •Bilirubin less than 2.0 mg/dL OR
• •SGOT less than 3 times upper limit of normal
• •Renal:
• •Creatinine less than 1.5 mg/dL OR
• •Creatinine clearance at least 60 mL/min
• •No history of nephrolithiasis
• •Must have 2 functioning kidneys
• •Cardiovascular:
• •No New York Heart Association class III or IV heart disease
• •Pulmonary:
• •No severe debilitating pulmonary disease
• •Metabolic:
• •No pre-existing endocrine or metabolic disorders that impact calcium regulatory axis including hypercalcemia (ionized serum calcium greater than 5.3 mg/dL or total calcium greater than 10.5 mg/dL) or hypercalciuria (greater than 300 mg urinary calcium/24 hours)
• •Other:
• •No active secondary malignancy except nonmelanoma skin cancer
• •Must maintain low calcium diet (less than 800 mg calcium daily)
• •No uncontrolled serious active infection
• •No history of malabsorption disorders
• •No history of inflammatory bowel disease
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Not specified
• •Chemotherapy:
• •See Disease Characteristics
• •At least 4 weeks since prior chemotherapy and recovered
• •No concurrent chemotherapy
• •Endocrine therapy:
• •See Disease Characteristics
• •Recovered from prior endocrine therapy
• •Radiotherapy:
• •See Disease Characteristics
• •At least 4 weeks since prior radiotherapy and recovered
• •No concurrent radiotherapy to sole measurable lesion
• •Surgery:
• •See Disease Characteristics
• •Recovered from prior surgery
• •No concurrent surgery to sole measurable lesion
• •Other:
• •No other concurrent cholecalciferol