Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy

NCT00054522 | Completed Phase 2 DMC

• 2 other identifiers: CDR0000270758RPCI-RP-0203
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Calcitriol may help tumor cells develop into normal cells. Dexamethasone may increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining calcitriol with dexamethasone in treating patients with prostate cancer who have undergone surgery or radiation therapy.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer

Interventions

calcitriol DIETARY_SUPPLEMENT

dexamethasone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate meeting all of the following criteria: * Curatively treated with radical prostatectomy OR definitive radiotherapy * No signs of clinical recurrence or dissemination of prostate cancer by digital rectal examination without tumor * No local recurrence by CT scan or MRI of the pelvis * No metastases by bone scan and chest x-ray NOTE: Prior Prostascint scans allowed regardless of results * At least 3 prostate-specific antigen (PSA) measurements obtained over at least 90 days after radical prostatectomy on post-radiotherapy PSA nadir must be available * PSA at least 2 ng/mL after prostatectomy OR at least 4 ng/mL after prior radiotherapy * Patients previously treated with radiotherapy must have a PSA clearly rising from lowest value within 6 months after completion of therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 12 months Hematopoietic * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN Renal * Creatinine less than 1.8 mg/dL * Phosphorus normal * No hypercalcemia (albumin-corrected calcium greater than ULN) * No nephrolithiasis * Single episode of renal lithiasis allowed provided episode occurred more than 5 years prior to study Other * Fertile patients must use effective double-barrier contraception for at least 1 week before, during, and for at least 2 weeks after study * No symptomatic pancreatitis * No uncontrolled diabetes * No known or suspected inability to comply with study requirements (e.g., abuse of alcohol/drugs or psychotic states) * Curatively treated condition associated with renal stones (e.g., hyperparathyroidism, bladder dysfunction, or obstructive uropathy) allowed provided patient has been free of stone formation for more than 5 years PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for prostate cancer * At least 24 months since prior chemotherapy for other diseases Endocrine therapy * More than 6 months since prior hormonal therapy, including neoadjuvant or adjuvant androgen deprivation therapy (e.g., luteinizing hormone-releasing hormone analogue or antiandrogen) * No prior androgen deprivation therapy of more than 8 months duration * No prior hormonal therapy for prostate cancer more than 3 months after definitive local therapy * No concurrent androgen therapy Radiotherapy * See Disease Characteristics * More than 3 months since prior radiotherapy for locally recurrent prostate cancer * No concurrent radiotherapy, including for pain control Surgery * See Disease Characteristics Other * More than 4 weeks since prior investigational drugs * No concurrent medication known to affect systemic calcium metabolism, including any of the following: * More than 400 IU of cholecalciferol supplements * More than 500 IU of vitamin A supplements * Calcium supplements * Fluoride * Antiepileptics

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 (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, 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

Study Officials

• Donald L. Trump, MD

  Roswell Park Cancer Institute

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: April 1, 2002
• Primary Completion: January 1, 2006
• Study Completion: March 1, 2006
• Last Updated: March 8, 2011

Record last verified: 2011-03

Locations

US (2)