Status:
TERMINATED
A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Novacea
Conditions:
Prostatic Neoplasms
Prostate Cancer
Eligibility:
MALE
18-90 years
Phase:
PHASE2
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 his...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00383487
Start Date
March 1 2005
End Date
July 1 2007
Last Update
January 28 2013
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305