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

Prostate Cancer Clinical Trial

Official title:

Phase II Study of Weekly Intravenous 1,25 Dihydroxycholecelciferol (Calcitriol) + Dexamethasone in Androgen Independent Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00524589
• Other study ID #: CDR0000563197
• Secondary ID: RPCI I-65405
• Status: Terminated
• Phase: Phase 2
• First received: August 31, 2007
• Last updated: October 17, 2017
• Start date: April 2006
• Est. completion date: September 2010

Study information

• Verified date: October 2017
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• calcitriol
IV

Drug:
• dexamethasone
Oral

Genetic:
• protein expression analysis
Correlative Study

Other:
• laboratory biomarker analysis
Correlative Study

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response (Complete or Partial Response)	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	1 year
Secondary	Corrected Serum Calcium Expression	Number of patients with corrected serum calcium levels between 11 mg/dL and 12 mg/dL detected on 1 or more occasions.	1 year