ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere
NCT ID: NCT00043576
Last Updated: 2009-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
250 participants
INTERVENTIONAL
2002-08-31
2005-12-31
Brief Summary
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Detailed Description
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Calcitriol, at very low doses, is currently approved for use in patients with chronic kidney failure. DN-101 was specifically designed for cancer and contains 30 times the amount of calcitriol found in the calcitriol pill commercially available today. In order to take an amount of calcitriol equivalent to 1 DN-101 pill, cancer patients would need to swallow 30 pills of the approved, low dose formulation. DN-101 represents a breakthrough in the use of calcitriol in the clinic, because it contains high concentrations of calcitriol and makes it more feasible for patients to stay on regimen.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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calcitriol
docetaxel
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Aventis Pharmaceuticals
INDUSTRY
Novacea
INDUSTRY
Principal Investigators
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Tomasz Beer, MD
Role: STUDY_CHAIR
Oregon Health and Science University
Locations
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Montgomery Cancer Center
Montgomery, Alabama, United States
Arizona Cancer Center- Scottsdale
Scottsdale, Arizona, United States
Arizona Cancer Center/Southern Arizona VA HCS
Tucson, Arizona, United States
Arizona Cancer Center- Tucson
Tucson, Arizona, United States
University of Arkansas for Medical Sciences / Central AR VA
Little Rock, Arkansas, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
California Cancer Care
Greenbrae, California, United States
Tower Hematology Oncology Medical Group
Los Angeles, California, United States
Prostate Oncology Specialist/Pacific Clinical Research
Marina del Rey, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Southern California Permanente Medical Group
San Diego, California, United States
Sharp Healthcare
San Diego, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
Kaiser- Northern California
Vallejo, California, United States
San Diego Cancer Center
Vista, California, United States
Oncology Hematology Associates, Paudre Calley Cancer Ctr.
Fort Collins, Colorado, United States
University of Miami-Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Oncology Hematology Consultants
Sarasota, Florida, United States
Georgia Urology, P.A.
Atlanta, Georgia, United States
Georgia Cancer Specialists
Tucker, Georgia, United States
Loyola University Medical
Maywood, Illinois, United States
Midwest Cancer Research Group
Skokie, Illinois, United States
Urologic Associates- P.C.
Davenport, Iowa, United States
Oncology Hematology Care
Crestview Hills, Kentucky, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Associates in Oncology Hematology P.C.
Rockville, Maryland, United States
Metro Minnesota CCOP
Saint Louis Park, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Univ. of Nebraska Medical Center/VA Hospital
Omaha, Nebraska, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Union State Bank Cancer Center
Nyack, New York, United States
Lincoln Medical & Mental Health Center
The Bronx, New York, United States
Raleigh Hematology Oncology Clinic
Cary, North Carolina, United States
The Cleveland Clinic Foundation, Taussig Cancer Center
Cleveland, Ohio, United States
Mid Ohio Oncology Hematology, Inc.
Columbus, Ohio, United States
Oregon Health & Sciences University
Portland, Oregon, United States
NW Kaiser Permanente Portland
Portland, Oregon, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Charleston Hematology Oncology
Charleston, South Carolina, United States
Medical University of South Carolina - Hollings Cancer Center
Charleston, South Carolina, United States
University Oncology/ Hematology Associates
Chattanooga, Tennessee, United States
Boston Baskin Cancer Group
Memphis, Tennessee, United States
Professional Quality Research
Austin, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Texas Cancer Care
Fort Worth, Texas, United States
Urology Associates of North Texas
Fort Worth, Texas, United States
North Texas Regional Cancer Center
Plano, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
University of Washington Cancer Care
Seattle, Washington, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Vancouver Cancer Center
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
London Regional Cancer Centre
London, Ontario, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
Toronto-Sunnybrook Regional Cancer Center
Toronto, Ontario, Canada
Princess Margaret Hospital, University Health Network
Toronto, Ontario, Canada
CHUM / Notre-Dame Hospital
Montreal, Quebec, Canada
Centre hospitalier universitaire de Quebec, Hotel-Dieu de Quebec
Québec, Quebec, Canada
Countries
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References
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Beer TM, Munar M, Henner WD. A Phase I trial of pulse calcitriol in patients with refractory malignancies: pulse dosing permits substantial dose escalation. Cancer. 2001 Jun 15;91(12):2431-9.
Beer TM, Eilers KM, Garzotto M, Egorin MJ, Lowe BA, Henner WD. Weekly high-dose calcitriol and docetaxel in metastatic androgen-independent prostate cancer. J Clin Oncol. 2003 Jan 1;21(1):123-8. doi: 10.1200/jco.2003.05.117.
Other Identifiers
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ASCENT Trial
Identifier Type: -
Identifier Source: secondary_id
DN101-002
Identifier Type: -
Identifier Source: org_study_id
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