A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer

NCT00383487 | Terminated Phase 2 DMC

• 2 other identifiers: PROS002195804
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether, in this patient population, treatment with calcitriol and Naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls.

Conditions

Prostatic Neoplasms; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.

Secondary Outcomes (1)

• Progressive disease in this study's patients, who would be treated with calcitriol and naprosyn, will be compared to that in historical controls of patients treated with calcitriol alone.

Interventions

Calcitriol DRUG

0.5 micrograms/kilogram q weekly

Also known as: 1,25-Dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3

Naproxen-n-butyl nitrate DRUG

400 mg BID, oral

Also known as: Naprosyn

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must give written informed consent
• Histologically confirmed adenocarcinoma of the prostate
• Biochemical relapse after primary radiation therapy or surgery
• Normal testosterone levels
• rising PSA after nadir, with interval between PSA determinations \> 2 weeks

You may not qualify if:

• Local recurrence by CT scan
• Distant metastases by bone scan
• Hypercalcemia
• Nephrolithiasis
• Renal insufficiency (serum creatinine \> 1.8 mg/dl)
• Pancreatitis
• History of ulcer or gastrointestinal bleeding
• More than 6 months of hormone ablation therapy
• Concurrent therapy for prostate cancer
• Uncontrolled HTN
• H/O MI, CVA, TIA
• Known coronary disease/cerebrovascular disease
• Platelet counts \<50
• Patients on anticoagulants
• Patients on lithium

Sponsors & Collaborators

• Stanford University: lead
• Novacea: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Calcitriol; naproxen-n-butyl nitrate; Naproxen

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; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Dr. Sandy Srinivas

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 3, 2006
• Study Start: March 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

US (1)