Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Novacea

Stanford Investigator(s):

Intervention(s):

  • Drug: Calcitriol
  • Drug: Naproxen-n-butyl nitrate

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - 90 Years

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Denise Haas
6507361252
Not Recruiting