Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: calcitriol; dexamethasone; protein expression analysis; laboratory biomarker analysis
Intervention description: IV; Oral; Correlative Study; Correlative Study
Intervention MeSH terms: Calcitriol; Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent prostate cancer

Summary:

      RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to
      grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor
      cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an
      effective treatment for prostate cancer that did not respond to hormone therapy .

      PURPOSE: This phase II trial is studying how well giving calcitriol together with
      dexamethasone works in treating patients with prostate cancer that did not respond to hormone
      therapy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  History of androgen-independent prostate cancer

               -  Evidence of rising PSA level (with or without new lesion by radiograph or
                  physical examination), defined as follows:

                    -  PSA level > 5 ng/mL and clearly rising on 2 measurements taken ≥ 2 weeks
                       apart after androgen deprivation therapy (i.e., orchiectomy or luteinizing
                       hormone-releasing hormone [LHRH] analogue) and antiandrogen withdrawal, if
                       appropriate

               -  PSA rising before and on the first value taken at 4 or 6 weeks after antiandrogen
                  cessation is considered disease progression

          -  Measurable or evaluable disease as defined by any of the following:

               -  Measurable or evaluable tumor masses by radiograph or physical examination

               -  Evaluable PSA

          -  Concurrent LHRH analogue or diethylstilbestrol (DES) for testicular androgen
             suppression required if no prior bilateral orchiectomy

               -  Patients receiving other monotherapy for testicular androgen suppression must
                  switch to a LHRH analogue or DES ≥ 14 days prior to study entry

        PATIENT CHARACTERISTICS:

          -  ECOG 0-2

          -  Life expectancy ≥ 12 weeks

          -  ANC ≥ 1,000/mm³

          -  Platelet count ≥ 75,000/mm³

          -  Hemoglobin > 8.9 g/dL (transfusion or erythropoietin support allowed)

          -  Serum creatinine ≤ 1.8 mg/dL

          -  AST ≤ 4 times upper limit of normal (ULN)

          -  Total bilirubin ≤ 2.0 mg/dL

          -  Serum corrected calcium < ULN

          -  No history of nephrolithiasis within the past 5 years

          -  No unstable, uncontrolled peptic ulcer disease, congestive heart failure, glaucoma,
             HIV, or diabetes

        PRIOR CONCURRENT THERAPY:

          -  At least 28 days since prior androgen deprivation therapy (≥ 42 days for bicalutamide)

               -  A 28-day washout period is not required for patients who have previously
                  progressed despite antiandrogen withdrawal and who have resumed antiandrogens
                  without reduction of PSA

          -  At least 14 days since prior radiotherapy

          -  At least 28 days since prior strontium 89

          -  At least 28 days since prior chemotherapy and/or investigational agents

          -  No concurrent medications or supplements that contain additional calcium (e.g., Tums)

          -  No concurrent radiotherapy for pain control or any other indication

          -  Concurrent bisphosphonates allowed provided dose/regimen is stable