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	Treatment or Intervention	Phase
Prostate Cancer	Drug: calcitriol  Drug: docetaxel	Phase II Phase III

Further Study Details: 

Expected Total Enrollment:  250

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male

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

Alabama
      Montgomery Cancer Center, Montgomery,  Alabama,  36106,  United States
Arizona
      Arizona Cancer Center- Tucson, Tucson,  Arizona,  85724,  United States
      Arizona Cancer Center- Scottsdale, Scottsdale,  Arizona,  85258,  United States
      Arizona Cancer Center/Southern Arizona VA HCS, Tucson,  Arizona,  85723,  United States
Arkansas
      University of Arkansas for Medical Sciences / Central AR VA, Little Rock,  Arkansas,  72205,  United States
California
      Sharp Healthcare, San Diego,  California,  92121,  United States
      Tower Hematology Oncology Medical Group, Los Angeles,  California,  90048,  United States
      California Cancer Care, Greenbrae,  California,  94904,  United States
      San Diego Cancer Center, Vista,  California,  92083,  United States
      Pacific Hematology Oncology Associates, San Francisco,  California,  94115,  United States
      Alta Bates Comprehensive Cancer Center, Berkeley,  California,  94704,  United States
      Prostate Oncology Specialist/Pacific Clinical Research, Marina Del Rey,  California,  90292,  United States
      Kaiser- Northern California, Vallejo,  California,  94589,  United States
      UC Davis Comprehensive Cancer Center, Sacramento,  California,  95817,  United States
      Southern California Permanente Medical Group, San Diego,  California,  92120,  United States
Colorado
      Oncology Hematology Associates, Paudre Calley Cancer Ctr., Fort Collins,  Colorado,  80528,  United States
Florida
      Oncology Hematology Consultants, Sarasota,  Florida,  34239,  United States
      University of Miami-Sylvester Comprehensive Cancer Center, Miami,  Florida,  33136,  United States
Georgia
      Georgia Cancer Specialists, Tucker,  Georgia,  30084,  United States
      Georgia Urology, P.A., Atlanta,  Georgia,  30342,  United States
Illinois
      Midwest Cancer Research Group, Skokie,  Illinois,  60077,  United States
      Loyola University Medical, Maywood,  Illinois,  60153,  United States
Iowa
      Urologic Associates- P.C., Davenport,  Iowa,  52807,  United States
Kentucky
      Oncology Hematology Care, Crestview Hills,  Kentucky,  41017,  United States
Louisiana
      Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112,  United States
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21232,  United States
      Associates in Oncology Hematology P.C., Rockville,  Maryland,  20850,  United States
Minnesota
      Metro Minnesota CCOP, St. Louis Park,  Minnesota,  55416,  United States
Missouri
      Missouri Cancer Associates, Columbia,  Missouri,  65201,  United States
Nebraska
      Univ. of Nebraska Medical Center/VA Hospital, Omaha,  Nebraska,  68198,  United States
New Mexico
      New Mexico Cancer Care Associates, Santa Fe,  New Mexico,  87505,  United States
New York
      Lincoln Medical & Mental Health Center, Bronx,  New York,  10459,  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
North Carolina
      Raleigh Hematology Oncology Clinic, Cary,  North Carolina,  27511,  United States
Ohio
      Mid Ohio Oncology Hematology, Inc., Columbus,  Ohio,  43222,  United States
      The Cleveland Clinic Foundation, Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
Oregon
      Oregon Health & Sciences University, Portland,  Oregon,  97201,  United States
      NW Kaiser Permanente Portland, Portland,  Oregon,  97227,  United States
Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15232,  United States
South Carolina
      Charleston Hematology Oncology, Charleston,  South Carolina,  29403,  United States
      Medical University of South Carolina - Hollings Cancer Center, Charleston,  South Carolina,  29425,  United States
Tennessee
      Boston Baskin Cancer Group, Memphis,  Tennessee,  38104,  United States
      University Oncology/ Hematology Associates, Chattanooga,  Tennessee,  37403,  United States
Texas
      Texas Cancer Care, Fort Worth,  Texas,  76104,  United States
      Professional Quality Research, Austin,  Texas,  78756,  United States
      Tyler Cancer Center, Tyler,  Texas,  75702,  United States
      North Texas Regional Cancer Center, Plano,  Texas,  75075,  United States
      Texas Oncology, P.A., Dallas,  Texas,  75246,  United States
      Urology Associates of North Texas, Ft. Worth,  Texas,  76104,  United States
Washington
      University of Washington Cancer Care, Seattle,  Washington,  98109,  United States
Canada
      Centre hospitalier universitaire de Quebec, Hotel-Dieu de Quebec, Quebec,  G1R 2J6,  Canada
Canada, Alberta
      Tom Baker Cancer Centre, Calgary,  Alberta,  T2N 4N2,  Canada
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada
Canada, British Columbia
      Vancouver Cancer Center, Vancouver,  British Columbia,  V5Z 4E6,  Canada
Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E OV9,  Canada
Canada, Ontario
      Princess Margaret Hospital, University Health Network, Toronto,  Ontario,  M5G 2M9,  Canada
      Toronto-Sunnybrook Regional Cancer Center, Toronto,  Ontario,  M4N 3M5,  Canada
      Princess Margaret Hospital, University Health Network, Toronto,  Ontario,  M5G 2M9,  Canada
      Ottawa Regional Cancer Centre, Ottawa,  Ontario,  K1H 1C4,  Canada
      London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada
Canada, Quebec
      CHUM / Notre-Dame Hospital, Montreal,  Quebec,  H2L 4M1,  Canada

Study chairs or principal investigators

Tomasz Beer, MD,  Study Chair,  Oregon Health and Science University   

Study ID Numbers:  DN101-002; ASCENT Trial
Record last reviewed:  February 2005
Last Updated:  February 8, 2005
Record first received:  August 9, 2002
ClinicalTrials.gov Identifier:  NCT00043576
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08