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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00383487
• Other study ID #: PROS0021
• Secondary ID: 95804
• Status: Terminated
• Phase: Phase 2
• First received: September 29, 2006
• Last updated: January 25, 2013
• Start date: March 2005
• Est. completion date: July 2007

Study information

• Verified date: January 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Calcitriol
0.5 micrograms/kilogram q weekly
• Naproxen-n-butyl nitrate
400 mg BID, oral

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Novacea

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.		unknown	No
Secondary	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.		unknown	No