A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
Trial ID or NCT#
NCT00383487
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
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
Investigator(s)
Sandy Srinivas
Medical oncologist,
Urologic specialist,
Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology
David Feldman
Contact us to find out if this trial is right for you.
Contact
Denise Haas
6507361252
View on ClinicalTrials.gov
