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

NCT00524589 | Terminated Phase 2 Results DMC

• 2 other identifiers: CDR0000563197RPCI I-65405
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Corrected Serum Calcium Expression

  1 year

Study Arms (1)

Dexamethasone and Calcitriol

EXPERIMENTAL

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

Dietary Supplement: calcitriol; Drug: dexamethasone; Genetic: protein expression analysis; Other: laboratory biomarker analysis

Interventions

calcitriol DIETARY_SUPPLEMENT

IV

Dexamethasone and Calcitriol

dexamethasone DRUG

Oral

Dexamethasone and Calcitriol

protein expression analysis GENETIC

Correlative Study

Dexamethasone and Calcitriol

laboratory biomarker analysis OTHER

Correlative Study

Dexamethasone and Calcitriol

Eligibility Criteria

• Age: Up to 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Calcitriol; Dexamethasone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids, Fluorinated

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Donald L. Trump, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 3, 2007
• Study Start: April 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 20, 2017
• Results First Posted: March 10, 2014

Record last verified: 2017-10

Locations

US (1)