A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
Information source: Stanford University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Neoplasms
Intervention: DN-101 (Drug); Naproxen (Naprosyn) (Drug)
Phase: Phase 2
Status: Suspended
Sponsored by: Stanford University Official(s) and/or principal investigator(s):
Dr. Sandy Srinivas, Principal Investigator, Affiliation: Stanford University
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.
Clinical Details
Official title: A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.
Secondary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Male.
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
Locations and Contacts
Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information
Starting date: March 2005
Last updated: May 22, 2008
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