David Feldman
A Phase II Trial of Calcitriol and Naproxen in Patients with Recurrent Prostate Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
SuspendedStanford Recruiting Status:
SuspendedCondition(s):
Intervention(s):
- Drug: DN-101
- Drug: Naproxen (Naprosyn)
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to 90 yearsGenders Eligible for Study:
MaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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
Key Exclusion Criteria:
Additional Study Details
Official Title:
A Phase II Trial of Calcitriol and Naproxen in Patients with Recurrent Prostate CancerAnticipated start date:
3/1/2005Lead Sponsor:
Stanford UniversityCollaborator(s):
- Novacea, Inc.
Investigator(s):
- Dr. Sandy Srinivas
- Natalia Colocci
- David Feldman
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.
Secondary Outcomes:
- 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.
Total Number to be Enrolled:
30Total Number to be Enrolled at Stanford:
30More Information
Secondary ID(s):
- 95804
- NCT00383487
- PROS0021
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/29/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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