ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere
A Phase 2/3 Multicenter, Randomized, Double Blind Study of Docetaxel (Taxotere) Plus DN-101 or Placebo in Androgen Independent Prostate Cancer (AIPC)
2 other identifiers
interventional
250
2 countries
62
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Aug 2002
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 9, 2002
CompletedFirst Posted
Study publicly available on registry
August 13, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedMarch 12, 2009
February 1, 2005
August 9, 2002
March 10, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Novacealead
- Aventis Pharmaceuticalscollaborator
Study Sites (62)
Montgomery Cancer Center
Montgomery, Alabama, 36106, United States
Arizona Cancer Center- Scottsdale
Scottsdale, Arizona, 85258, United States
Arizona Cancer Center/Southern Arizona VA HCS
Tucson, Arizona, 85723, United States
Arizona Cancer Center- Tucson
Tucson, Arizona, 85724, United States
University of Arkansas for Medical Sciences / Central AR VA
Little Rock, Arkansas, 72205, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704, United States
California Cancer Care
Greenbrae, California, 94904, United States
Tower Hematology Oncology Medical Group
Los Angeles, California, 90048, United States
Prostate Oncology Specialist/Pacific Clinical Research
Marina del Rey, California, 90292, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Southern California Permanente Medical Group
San Diego, California, 92120, United States
Sharp Healthcare
San Diego, California, 92121, United States
Pacific Hematology Oncology Associates
San Francisco, California, 94115, United States
Kaiser- Northern California
Vallejo, California, 94589, United States
San Diego Cancer Center
Vista, California, 92083, United States
Oncology Hematology Associates, Paudre Calley Cancer Ctr.
Fort Collins, Colorado, 80528, United States
University of Miami-Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Oncology Hematology Consultants
Sarasota, Florida, 34239, United States
Georgia Urology, P.A.
Atlanta, Georgia, 30342, United States
Georgia Cancer Specialists
Tucker, Georgia, 30084, United States
Loyola University Medical
Maywood, Illinois, 60153, United States
Midwest Cancer Research Group
Skokie, Illinois, 60077, United States
Urologic Associates- P.C.
Davenport, Iowa, 52807, United States
Oncology Hematology Care
Crestview Hills, Kentucky, 41017, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112, United States
Johns Hopkins University
Baltimore, Maryland, 21232, United States
Associates in Oncology Hematology P.C.
Rockville, Maryland, 20850, United States
Metro Minnesota CCOP
Saint Louis Park, Minnesota, 55416, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Univ. of Nebraska Medical Center/VA Hospital
Omaha, Nebraska, 68198, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Union State Bank Cancer Center
Nyack, New York, 10960, United States
Lincoln Medical & Mental Health Center
The Bronx, New York, 10459, United States
Raleigh Hematology Oncology Clinic
Cary, North Carolina, 27511, United States
The Cleveland Clinic Foundation, Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Mid Ohio Oncology Hematology, Inc.
Columbus, Ohio, 43222, United States
Oregon Health & Sciences University
Portland, Oregon, 97201, United States
NW Kaiser Permanente Portland
Portland, Oregon, 97227, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
Charleston Hematology Oncology
Charleston, South Carolina, 29403, United States
Medical University of South Carolina - Hollings Cancer Center
Charleston, South Carolina, 29425, United States
University Oncology/ Hematology Associates
Chattanooga, Tennessee, 37403, United States
Boston Baskin Cancer Group
Memphis, Tennessee, 38104, United States
Professional Quality Research
Austin, Texas, 78756, United States
Texas Oncology, P.A.
Dallas, Texas, 75246, United States
Texas Cancer Care
Fort Worth, Texas, 76104, United States
Urology Associates of North Texas
Fort Worth, Texas, 76104, United States
North Texas Regional Cancer Center
Plano, Texas, 75075, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
University of Washington Cancer Care
Seattle, Washington, 98109, United States
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Vancouver Cancer Center
Vancouver, British Columbia, V5Z 4E6, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E OV9, Canada
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4, Canada
Toronto-Sunnybrook Regional Cancer Center
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital, University Health Network
Toronto, Ontario, M5G 2M9, Canada
CHUM / Notre-Dame Hospital
Montreal, Quebec, H2L 4M1, Canada
Centre hospitalier universitaire de Quebec, Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6, Canada
Related Publications (2)
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.
PMID: 11413535BACKGROUNDBeer 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.
PMID: 12506180BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tomasz Beer, MD
Oregon Health and Science University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 9, 2002
First Posted
August 13, 2002
Study Start
August 1, 2002
Study Completion
December 1, 2005
Last Updated
March 12, 2009
Record last verified: 2005-02