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A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
Not Recruiting
Trial ID: NCT00383487
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.
Official Title
A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
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
Intervention(s):
drug: Calcitriol
drug: Naproxen-n-butyl nitrate
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Denise Haas
6507361252