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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00524589
Enrollment
18
Registered
2007-09-03
Start date
2006-04-30
Completion date
2010-09-30
Last updated
2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer

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.

Interventions

DIETARY_SUPPLEMENTcalcitriol

IV

DRUGdexamethasone

Oral

GENETICprotein expression analysis

Correlative Study

OTHERlaboratory biomarker analysis

Correlative Study

Sponsors

Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
No minimum to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Objective Response (Complete or Partial Response)1 yearPer 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

MeasureTime frameDescription
Corrected Serum Calcium Expression1 yearNumber of patients with corrected serum calcium levels between 11 mg/dL and 12 mg/dL detected on 1 or more occasions.

Countries

United States

Participant flow

Participants by arm

ArmCount
Dexamethasone and Calcitriol
Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly. calcitriol: IV dexamethasone: Oral protein expression analysis: Correlative Study laboratory biomarker analysis: Correlative Study
18
Total18

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDisease Progression16
Overall StudyWithdrawal by Subject2

Baseline characteristics

CharacteristicDexamethasone and Calcitriol
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
11 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
Age, Continuous68.2 years
STANDARD_DEVIATION 11.8
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
18 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
18 / 18
serious
Total, serious adverse events
4 / 18

Outcome results

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.

Time frame: 1 year

Population: All treated and eligible patients

ArmMeasureValue (NUMBER)
Dexamethasone and CalcitriolObjective Response (Complete or Partial Response)0 percentage of participants
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.

Time frame: 1 year

Population: All treated and eligible patients

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Dexamethasone and CalcitriolCorrected Serum Calcium Expression6 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026