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

• ClinicalTrials.gov Identifier: NCT00383487
• Recruitment Status: Terminated
• First Posted: October 3, 2006
• Last Update Posted: January 28, 2013
• Sponsor: Stanford University
• Collaborator: Novacea
• Information provided by (Responsible Party): Sandy Srinivas, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostatic Neoplasms; Prostate Cancer	Drug: Calcitriol; Drug: Naproxen-n-butyl nitrate	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• 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
• Study Start Date: March 2005
• Actual Primary Completion Date: July 2007
• Actual Study Completion Date: July 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: PROS0021; 95804 ( Other Identifier: Stanford University alternate IRB Number )
• 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; Prostatic Diseases; Calcitriol; Dihydroxycholecalciferols; Naproxen; 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-Regulating Hormones and Agents; Calcium Channel Agonists; Membrane Transport Modulators; Vasoconstrictor Agents; Vitamins; Micronutrients; Bone Density Conservation Agents; Nitric Oxide Donors