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Home > "A" Clinical Trials Conditions > ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere  ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere
ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere
For Condition: Prostate Cancer
Status: No longer recruiting
Sponsor(s): Novacea , Aventis Pharmaceuticals
Synopsis: The purposes of this study are to determine if DN-101 plus Taxotere lowers PSA levels, delays or limits disease progression and is safe with minimal side effects.
Details: DN-101 is an experimental drug that has not been approved. It is a newly formulated pill that contains high amounts of calcitriol, a naturally occurring hormone and the biologically active form of vitamin D. The natural vitamin D found in dairy products or in typical vitamin pills, must be chemically changed by the liver and kidney into calcitriol before it is biologically active. In laboratory and animal models, high doses of calcitriol enhanced the effect of many commonly used chemotherapeutic agents, producing anti-tumor activity in many cancers. In another Phase 2 AIPC study, the combination of high doses of commercially available calcitriol and Taxotere appeared active in patients as measured by PSA levels. Thirty out of 37 patients who received the combination treatment had a decrease in PSA level that lasted for a longer period of time compared to patients in other studies who received Taxotere alone. The goal of the current Phase 2/3 study is to confirm the previous Phase 2 results in a controlled way (comparing DN-101 against a placebo/sugar pill). In particular, the purposes of this study are to determine if DN-101 plus Taxotere lowers PSA levels, delays or limits disease progression, and is safe with minimal side effects.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: - Three rising PSA measurements OR a new metastatic lesion - Adequate liver and kidney function - Ongoing hormonal therapy - No hospitalization for angina, heart attack or congestive heart failure within the last 12 months - No kidney stones in the last 5 years
Total Enrollment: 232
Location and Contact Information:
Overall Study Official:
TomaszBeer, Study Chair, Oregon Health and Science University
Georgia Cancer Specialists
Tucker, Georgia, 30084
United States
Texas Oncology, P.A.
Dallas, Texas, 75246
United States
Lincoln Medical & Mental Health Center
Bronx, New York, 10459
United States
North Texas Regional Cancer Center
Plano, Texas, 75075
United States
Pacific Hematology Oncology Associates
San Francisco, California, 94115
United States
Professional Quality Research
Austin, Texas, 78756
United States
Oncology Hematology Associates, Paudre Calley Cancer Ctr.
Fort Collins, Colorado, 80528
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Associates in Oncology Hematology P.C.
Rockville, Maryland, 20850
United States
Tower Hematology Oncology Medical Group
Los Angeles, California, 90048
United States
Kaiser- Northern California
Vallejo, California, 94589
United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505
United States
University of Miami-Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
Oregon Health & Sciences University
Portland, Oregon, 97201
United States
Oncology Hematology Care
Crestview, Kentucky, 41017
United States
CancerCare Manitoba
Winnipeg, Manitoba, R3E OV9
Canada
Princess Margaret Hospital, University Health Network
Toronto, Ontario, M5G 2M9
Canada
Urologic Associates- P.C.
Davenport, Iowa, 52807
United States
Raleigh Hematology Oncology Clinic
Cary, North Carolina, 27511
United States
Boston Baskin Cancer Group
Memphis, Tennessee, 38104
United States
Southern California Permanente Medical Group
San Diego, California, 92120
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112
United States
North Texas Urologic Association Clinical Research
Ft. Worth, Texas, 76104
United States
NW Kaiser Permanente Portland
Portland, Oregon, 97227
United States
Arizona Cancer Center- Scottsdale
Scottsdale, Arizona, 85258
United States
Missouri Cancer Associates
Columbia, Missouri, 65201
United States
London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Midwest Cancer Research Group
Skokie, Illinois, 60077
United States
Columbia Presbyterian Medical Center
New York City, New York, 10032
United States
University of Arkansas for Medical Sciences / Central AR VA
Little Rock, Arkansas, 72205
United States
Prostate Oncology Specialist/Pacific Clinical Research
Marina Del Rey, California, 90292
United States
Arizona Cancer Center- Tucson
Tucson, Arizona, 85724
United States
Univ. of Nebraska Medical Center/VA Hospital
Omaha, Nebraska, 68198
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
CHUM / Notre-Dame Hospital
Montreal, Quebec, H2L 4M1
Canada
Princess Margaret Hospital, University Health Network
Toronto, Ontario, M5G 2M9
Canada
California Cancer Care
Greenbrae, California, 94904
United States
Texas Cancer Care
Ft. Worth, Texas, 76104
United States
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Canada
University of Washington Cancer Care
Seattle, Washington, 98109
United States
Montgomery Cancer Center
Montgomery, Alabama, 36106
United States
Mid Ohio Oncology Hematology
Columbus, Ohio, 43222
United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
United States
Johns Hopkins University
Baltimore, Maryland, 21232
United States
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Sharp Healthcare
San Diego, California, 92121
United States
Georgia Urology, P.A.
Atlanta, Georgia, 30342
United States
Metro Minnesota CCOP
St. Louis Park, Minnesota, 55416
United States
The Cleveland Clinic Foundation, Taussig Cancer Center
Cleveland, Ohio, 44195
United States
San Diego Cancer Center
Vista, California, 92083
United States
Vancouver Cancer Center
Vancouver, British Columbia, V5Z 4E6
Canada
Charleston Hematology Oncology
Charleston, South Carolina, 29403
United States
Arizona Cancer Center/Southern Arizona VA HCS
Tucson, Arizona, 85723
United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
Toronto-Sunnybrook Regional Cancer Center
Toronto, Ontario, M4N 3M5
Canada
Oncology Hematology Consultants
Sarasota, Florida, 34239
United States
Loyola University Medical
Maywood, Illinois, 60153
United States
Union State Bank Cancer Center
Nyack, New York, 10960
United States
Tyler Cancer Center
Tyler, Texas, 75702
United States
Additional Information:
Study ID Numbers: DN101-002; ASCENT Trial
Study Start Date: August 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043576
Other Prostate Cancer Studies:
1. PSA-Based Vaccine and Radiotherapy to Treat Localized Prostate Cancer
2. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
3. Analysis of Prostate Cancer Short-Term Cultures Using Molecular Cytogenetic Methods
4. Treatment of Erectile Dysfunction (ED) in Patients Treated for Prostate Cancer
5. YM598 in patients with rising PSA after initial therapy for localized prostate cancer
Related Studies:
Other Prostate Cancer Clinical Trials
Other Florida Clinical Trials
Other Sarasota Clinical Trials
ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere
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