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A Phase 2/3 Multicenter, Randomized, Double Blind Study of Docetaxel (Taxotere) Plus DN-101 or Placebo in Androgen Independent Prostate Cancer (AIPC)

Phase 2/Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A Phase 2/3 Multicenter, Randomized, Double Blind Study of Docetaxel (Taxotere) Plus DN-101 or Placebo in Androgen Independent Prostate Cancer (AIPC)

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.

Inclusion 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Tomasz Beer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oregon Health and Science University


United States: Food and Drug Administration

Study ID:




Start Date:

August 2002

Completion Date:

December 2005

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Androgen Independent Prostate Cancer
  • Prostatic Neoplasms



Johns Hopkins University Baltimore, Maryland  21205
Roswell Park Cancer Institute Buffalo, New York  14263
Texas Oncology, P.A. Dallas, Texas  75246
Southern California Permanente Medical Group Downey, California  90242
Georgia Cancer Specialists Decatur, Georgia  30033
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
Missouri Cancer Associates Columbia, Missouri  65201
Urology Associates of North Texas Arlington, Texas  76015
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
Texas Cancer Care Fort Worth, Texas  76104
Montgomery Cancer Center Montgomery, Alabama  36106-3657
Tower Hematology Oncology Medical Group Los Angeles, California  90048
University of Pittsburgh Pittsburgh, Pennsylvania  15261
Tyler Cancer Center Tyler, Texas  75702
Boston Baskin Cancer Group Memphis, Tennessee  38104
Oncology Hematology Consultants Sarasota, Florida  34239
Metro Minnesota CCOP St. Louis Park, Minnesota  55416
Midwest Cancer Research Group Skokie, Illinois  60077
Columbia Presbyterian Medical Center New York, New York  10032
Arizona Cancer Center- Scottsdale Scottsdale, Arizona  85258
Arizona Cancer Center- Tucson Tucson, Arizona  85724
Arizona Cancer Center/Southern Arizona VA HCS Tucson, Arizona  85723
University of Arkansas for Medical Sciences / Central AR VA Little Rock, Arkansas  72205
California Cancer Care Greenbrae, California  94904
Prostate Oncology Specialist/Pacific Clinical Research Marina Del Rey, California  90292
UC Davis Comprehensive Cancer Center Sacramento, California  95817
Sharp Healthcare San Diego, California  92121
Pacific Hematology Oncology Associates San Francisco, California  94115
Kaiser- Northern California Vallejo, California  94589
San Diego Cancer Center Vista, California  92083
Oncology Hematology Associates, Paudre Calley Cancer Ctr. Fort Collins, Colorado  80528
University of Miami-Sylvester Comprehensive Cancer Center Miami, Florida  33136
Georgia Urology, P.A. Atlanta, Georgia  30342
Loyola University Medical Maywood, Illinois  60153
Urologic Associates- P.C. Davenport, Iowa  52807
Oncology Hematology Care Crestview HIlls, Kentucky  41017
Tulane University Hospital and Clinic New Orleans, Louisiana  70112
Associates in Oncology Hematology P.C. Rockville, Maryland  20850
Univ. of Nebraska Medical Center/VA Hospital Omaha, Nebraska  68198
Lincoln Medical & Mental Health Center Bronx, New York  10459
Union State Bank Cancer Center Nyack, New York  10960
Raleigh Hematology Oncology Clinic Cary, North Carolina  27511
The Cleveland Clinic Foundation, Taussig Cancer Center Cleveland, Ohio  44195
Mid Ohio Oncology Hematology, Inc. Columbus, Ohio  43222
Oregon Health & Sciences University Portland, Oregon  97201
NW Kaiser Permanente Portland Portland, Oregon  97227
Charleston Hematology Oncology Charleston, South Carolina  29403
Medical University of South Carolina - Hollings Cancer Center Charleston, South Carolina  29425
University Oncology/ Hematology Associates Chattanooga, Tennessee  37403
Professional Quality Research Austin, Texas  78756
North Texas Regional Cancer Center Plano, Texas  75075
University of Washington Cancer Care Seattle, Washington  98109