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| Sponsor: | Novacea |
|---|---|
| Collaborator: |
Aventis Pharmaceuticals |
| Information provided by: | Novacea |
| ClinicalTrials.gov Identifier: | NCT00043576 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: calcitriol Drug: docetaxel |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 2/3 Multicenter, Randomized, Double Blind Study of Docetaxel (Taxotere) Plus DN-101 or Placebo in Androgen Independent Prostate Cancer (AIPC) |
| Estimated Enrollment: | 250 |
| Study Start Date: | August 2002 |
| Estimated Study Completion Date: | December 2005 |
DN-101 is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA). It is a newly formulated pill that contains high amounts of calcitriol, a naturally occurring hormone and the biologically active form of vitamin D. Administration of DN-101 results in much higher blood levels of calcitriol than the body can produce from dietary vitamin D or vitamin D supplements. These higher levels of calcitriol are associated with anti-cancer effects in laboratory models of human cancer. Laboratory models also indicate that calcitriol has synergy with many commonly used chemotherapeutic agents used to treat cancer.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Montgomery Cancer Center | |
| Montgomery, Alabama, United States, 36106 | |
| United States, Arizona | |
| Arizona Cancer Center- Tucson | |
| Tucson, Arizona, United States, 85724 | |
| Arizona Cancer Center- Scottsdale | |
| Scottsdale, Arizona, United States, 85258 | |
| Arizona Cancer Center/Southern Arizona VA HCS | |
| Tucson, Arizona, United States, 85723 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences / Central AR VA | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Sharp Healthcare | |
| San Diego, California, United States, 92121 | |
| Tower Hematology Oncology Medical Group | |
| Los Angeles, California, United States, 90048 | |
| Southern California Permanente Medical Group | |
| San Diego, California, United States, 92120 | |
| San Diego Cancer Center | |
| Vista, California, United States, 92083 | |
| Pacific Hematology Oncology Associates | |
| San Francisco, California, United States, 94115 | |
| Alta Bates Comprehensive Cancer Center | |
| Berkeley, California, United States, 94704 | |
| Prostate Oncology Specialist/Pacific Clinical Research | |
| Marina Del Rey, California, United States, 90292 | |
| Kaiser- Northern California | |
| Vallejo, California, United States, 94589 | |
| UC Davis Comprehensive Cancer Center | |
| Sacramento, California, United States, 95817 | |
| California Cancer Care | |
| Greenbrae, California, United States, 94904 | |
| United States, Colorado | |
| Oncology Hematology Associates, Paudre Calley Cancer Ctr. | |
| Fort Collins, Colorado, United States, 80528 | |
| United States, Florida | |
| Oncology Hematology Consultants | |
| Sarasota, Florida, United States, 34239 | |
| University of Miami-Sylvester Comprehensive Cancer Center | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Georgia Cancer Specialists | |
| Tucker, Georgia, United States, 30084 | |
| Georgia Urology, P.A. | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| Midwest Cancer Research Group | |
| Skokie, Illinois, United States, 60077 | |
| Loyola University Medical | |
| Maywood, Illinois, United States, 60153 | |
| United States, Iowa | |
| Urologic Associates- P.C. | |
| Davenport, Iowa, United States, 52807 | |
| United States, Kentucky | |
| Oncology Hematology Care | |
| Crestview HIlls, Kentucky, United States, 41017 | |
| United States, Louisiana | |
| Tulane University Hospital and Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21232 | |
| Associates in Oncology Hematology P.C. | |
| Rockville, Maryland, United States, 20850 | |
| United States, Minnesota | |
| Metro Minnesota CCOP | |
| St. Louis Park, Minnesota, United States, 55416 | |
| United States, Missouri | |
| Missouri Cancer Associates | |
| Columbia, Missouri, United States, 65201 | |
| United States, Nebraska | |
| Univ. of Nebraska Medical Center/VA Hospital | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Mexico | |
| New Mexico Cancer Care Associates | |
| Santa Fe, New Mexico, United States, 87505 | |
| United States, New York | |
| Lincoln Medical & Mental Health Center | |
| Bronx, New York, United States, 10459 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Columbia Presbyterian Medical Center | |
| New York, New York, United States, 10032 | |
| Union State Bank Cancer Center | |
| Nyack, New York, United States, 10960 | |
| United States, North Carolina | |
| Raleigh Hematology Oncology Clinic | |
| Cary, North Carolina, United States, 27511 | |
| United States, Ohio | |
| Mid Ohio Oncology Hematology, Inc. | |
| Columbus, Ohio, United States, 43222 | |
| The Cleveland Clinic Foundation, Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| Oregon Health & Sciences University | |
| Portland, Oregon, United States, 97201 | |
| NW Kaiser Permanente Portland | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, South Carolina | |
| Charleston Hematology Oncology | |
| Charleston, South Carolina, United States, 29403 | |
| Medical University of South Carolina - Hollings Cancer Center | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Boston Baskin Cancer Group | |
| Memphis, Tennessee, United States, 38104 | |
| University Oncology/ Hematology Associates | |
| Chattanooga, Tennessee, United States, 37403 | |
| United States, Texas | |
| Texas Cancer Care | |
| Fort Worth, Texas, United States, 76104 | |
| Professional Quality Research | |
| Austin, Texas, United States, 78756 | |
| Tyler Cancer Center | |
| Tyler, Texas, United States, 75702 | |
| North Texas Regional Cancer Center | |
| Plano, Texas, United States, 75075 | |
| Texas Oncology, P.A. | |
| Dallas, Texas, United States, 75246 | |
| Urology Associates of North Texas | |
| Ft. Worth, Texas, United States, 76104 | |
| United States, Washington | |
| University of Washington Cancer Care | |
| Seattle, Washington, United States, 98109 | |
| Canada | |
| Centre hospitalier universitaire de Quebec, Hotel-Dieu de Quebec | |
| Quebec, Canada, G1R 2J6 | |
| Canada, Alberta | |
| Tom Baker Cancer Centre | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| Vancouver Cancer Center | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E OV9 | |
| Canada, Ontario | |
| Princess Margaret Hospital, University Health Network | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Toronto-Sunnybrook Regional Cancer Center | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Canada, Quebec | |
| CHUM / Notre-Dame Hospital | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Study Chair: | Tomasz Beer, MD | Oregon Health and Science University |
More Information
| Study ID Numbers: | DN101-002, ASCENT Trial |
| Study First Received: | August 9, 2002 |
| Last Updated: | March 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00043576 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Prostate Cancer Androgen Independent Prostate Cancer |
|
Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Calcium Channel Agonists Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Bone Density Conservation Agents Hormones Calcitriol Docetaxel Membrane Transport Modulators |
Neoplasms by Site Vitamins Therapeutic Uses Vasoconstrictor Agents Micronutrients Growth Substances Cardiovascular Agents Genital Diseases, Male Pharmacologic Actions Neoplasms Prostatic Neoplasms Androgens |
