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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:
Collaborator:
Novacea
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University
ClinicalTrials.gov Identifier:
NCT00383487
First received: September 29, 2006
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression. [ Time Frame: unknown ] [ Designated as safety issue: No ]

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. [ Time Frame: unknown ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00383487     History of Changes
Other Study ID Numbers: PROS0021, 95804
Study First Received: September 29, 2006
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013