Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Roswell Park Cancer Institute
OBJECTIVES:
* To investigate the response rate in patients with androgen-independent prostate cancer treated with calcitriol and dexamethasone.
* To evaluate the toxicity of high-dose calcitriol and dexamethasone in these patients.
OUTLINE: Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and on days 2 and 3 to assess VDR and CYP24 expression in peripheral blood mononuclear cells.
Age
0–120
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
