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

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

calcitriol

dexamethasone

protein expression analysis

laboratory biomarker analysis

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dexamethasone and Calcitriol

Arm Description

Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00524589

First Posted

August 31, 2007

Last Updated

October 17, 2017

Sponsor

Roswell Park Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT00524589

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Terminated

Why Stopped

closed due to futility

Study Start Date

April 2006 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

recurrent prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone and Calcitriol

Arm Type

Experimental

Arm Description

Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.

Intervention Type

Dietary Supplement

Intervention Name(s)

calcitriol

Intervention Description

Intervention Type

Drug

Intervention Name(s)

dexamethasone

Intervention Description

Oral

Intervention Type

Genetic

Intervention Name(s)

protein expression analysis

Intervention Description

Correlative Study

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Description

Correlative Study

Primary Outcome Measure Information:

Title

Objective Response (Complete or Partial Response)

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Corrected Serum Calcium Expression

Description

Number of patients with corrected serum calcium levels between 11 mg/dL and 12 mg/dL detected on 1 or more occasions.

Time Frame

1 year

10. Eligibility

Sex

Male

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald L. Trump, MD

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263-0001

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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