Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

Roswell Park Comprehensive Cancer Center

Status and phase

Terminated

Phase 2

Conditions

Prostate Cancer

Treatments

Dietary Supplement: calcitriol

Drug: dexamethasone

Other: laboratory biomarker analysis

Genetic: protein expression analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT00524589

RPCI I-65405 (Other Identifier)

CDR0000563197

Details and patient eligibility

About

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.

Full description

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.

Enrollment

18 patients

Sex

Male

Ages

Under 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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