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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 UniversityBaltimore, Maryland  21205
Roswell Park Cancer InstituteBuffalo, New York  14263
Texas Oncology, P.A.Dallas, Texas  75246
Southern California Permanente Medical GroupDowney, California  90242
Georgia Cancer SpecialistsDecatur, Georgia  30033
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Missouri Cancer AssociatesColumbia, Missouri  65201
Urology Associates of North TexasArlington, Texas  76015
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
Texas Cancer CareFort Worth, Texas  76104
Montgomery Cancer CenterMontgomery, Alabama  36106-3657
Tower Hematology Oncology Medical GroupLos Angeles, California  90048
University of PittsburghPittsburgh, Pennsylvania  15261
Tyler Cancer CenterTyler, Texas  75702
Boston Baskin Cancer GroupMemphis, Tennessee  38104
Oncology Hematology ConsultantsSarasota, Florida  34239
Metro Minnesota CCOPSt. Louis Park, Minnesota  55416
Midwest Cancer Research GroupSkokie, Illinois  60077
Columbia Presbyterian Medical CenterNew York, New York  10032
Arizona Cancer Center- ScottsdaleScottsdale, Arizona  85258
Arizona Cancer Center- TucsonTucson, Arizona  85724
Arizona Cancer Center/Southern Arizona VA HCSTucson, Arizona  85723
University of Arkansas for Medical Sciences / Central AR VALittle Rock, Arkansas  72205
California Cancer CareGreenbrae, California  94904
Prostate Oncology Specialist/Pacific Clinical ResearchMarina Del Rey, California  90292
UC Davis Comprehensive Cancer CenterSacramento, California  95817
Sharp HealthcareSan Diego, California  92121
Pacific Hematology Oncology AssociatesSan Francisco, California  94115
Kaiser- Northern CaliforniaVallejo, California  94589
San Diego Cancer CenterVista, California  92083
Oncology Hematology Associates, Paudre Calley Cancer Ctr.Fort Collins, Colorado  80528
University of Miami-Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Georgia Urology, P.A.Atlanta, Georgia  30342
Loyola University MedicalMaywood, Illinois  60153
Urologic Associates- P.C.Davenport, Iowa  52807
Oncology Hematology CareCrestview HIlls, Kentucky  41017
Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Associates in Oncology Hematology P.C.Rockville, Maryland  20850
Univ. of Nebraska Medical Center/VA HospitalOmaha, Nebraska  68198
Lincoln Medical & Mental Health CenterBronx, New York  10459
Union State Bank Cancer CenterNyack, New York  10960
Raleigh Hematology Oncology ClinicCary, North Carolina  27511
The Cleveland Clinic Foundation, Taussig Cancer CenterCleveland, Ohio  44195
Mid Ohio Oncology Hematology, Inc.Columbus, Ohio  43222
Oregon Health & Sciences UniversityPortland, Oregon  97201
NW Kaiser Permanente PortlandPortland, Oregon  97227
Charleston Hematology OncologyCharleston, South Carolina  29403
Medical University of South Carolina - Hollings Cancer CenterCharleston, South Carolina  29425
University Oncology/ Hematology AssociatesChattanooga, Tennessee  37403
Professional Quality ResearchAustin, Texas  78756
North Texas Regional Cancer CenterPlano, Texas  75075
University of Washington Cancer CareSeattle, Washington  98109