A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer - Full Text View

Sponsor:	Stanford University
Collaborator:	Novacea
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	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.

Condition	Intervention	Phase
Prostatic Neoplasms	Drug: DN-101 Drug: Naproxen (Naprosyn)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Naproxen Naproxen sodium Calcitriol

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression. [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2005
Estimated Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

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 and NSAIDs both exert their antiproliferative effect by decreasing prostaglandin levels, but they do so by different mechanisms. Thus, there is reason to believe that their combined effects on prostaglandins may be synergistic. Preliminary in vitro assays in which calcitriol is given in combination with one of two different NSAIDs (Naprosyn or sulindac) to LNCaP cell lines have indicated such synergy. This observation provides the rational for using them in combination for the treatment of prostate cancer. In addition, it is hoped that any synergy noted would allow for the use of lower doses of NSAIDs.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383487

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Novacea

Investigators

Principal Investigator:

Dr. Sandy Srinivas

Stanford University

More Information

No publications provided

Responsible Party:	Stanford University School of Medicine ( Dr. Sandy Srinivas )
Study ID Numbers:	PROS0021, 95804, NCT00383487, PROS0021
Study First Received:	September 29, 2006
Last Updated:	October 6, 2009
ClinicalTrials.gov Identifier:	NCT00383487 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prostatic Diseases
Genital Neoplasms, Male
Molecular Mechanisms of Pharmacological Action
Calcium Channel Agonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Urogenital Neoplasms
Gout Suppressants
Calcitriol
Membrane Transport Modulators
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Vitamins

Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal
Micronutrients
Analgesics
Naproxen
Growth Substances
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Genital Diseases, Male
Pharmacologic Actions
Neoplasms
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 08, 2010