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

This study has been terminated.
(Extreme toxicity)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00383487
First Posted: October 3, 2006
Last Update Posted: January 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novacea
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University
  Purpose
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.

Condition Intervention Phase
Prostatic Neoplasms Prostate Cancer Drug: Calcitriol Drug: Naproxen-n-butyl nitrate Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Sandy Srinivas, Stanford University:

Primary Outcome Measures:
  • PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.

Secondary Outcome Measures:
  • 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.

Enrollment: 20
Study Start Date: March 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Calcitriol
    0.5 micrograms/kilogram q weekly
    Other Names:
    • 1,25-Dihydroxycholecalciferol
    • 1,25-dihydroxyvitamin D3
    Drug: Naproxen-n-butyl nitrate
    400 mg BID, oral
    Other Name: Naprosyn
Detailed Description:
In summary, in vitro and in vivo studies, as well as early phase clinical trial, have shown a promising role for both calcitriol and NSAIDs in the treatment of prostate cancer. Moreover, calcitriol and NSAIDs both exert their antiproliferative effect by decreasing prostaglandin levels, but they do so by different mechanisms. Thus, there is reason to believe that their combined effects on prostaglandins may be synergistic. Preliminary in vitro assays in which calcitriol is given in combination with one of two different NSAIDs (Naprosyn or sulindac) to LNCaP cell lines have indicated such synergy. This observation provides the rational for using them in combination for the treatment of prostate cancer. In addition, it is hoped that any synergy noted would allow for the use of lower doses of NSAIDs.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383487


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Novacea
Investigators
Principal Investigator: Dr. Sandy Srinivas Stanford University
  More Information

Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00383487     History of Changes
Other Study ID Numbers: PROS0021
95804 ( Other Identifier: Stanford University alternate IRB Number )
First Submitted: September 29, 2006
First Posted: October 3, 2006
Last Update Posted: January 28, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Naproxen
Calcitriol
Dihydroxycholecalciferols
Naproxen-n-butyl nitrate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents