Clinical trial NCT00043576: ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Androgen Independent Prostate Cancer
Lead sponsor: Novacea
Sponsor class: INDUSTRY
Collaborators: name: Aventis Pharmaceuticals
First posted: 2002-08-13
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Montgomery Cancer Center
state: Alabama
city: Scottsdale
country: United States
facility: Arizona Cancer Center- Scottsdale
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center/Southern Arizona VA HCS
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center- Tucson
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences / Central AR VA
state: Arkansas
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Greenbrae
country: United States
facility: California Cancer Care
state: California
city: Los Angeles
country: United States
facility: Tower Hematology Oncology Medical Group
state: California
city: Marina Del Rey
country: United States
facility: Prostate Oncology Specialist/Pacific Clinical Research
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: San Diego
country: United States
facility: Southern California Permanente Medical Group
state: California
city: San Diego
country: United States
facility: Sharp Healthcare
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: Vallejo
country: United States
facility: Kaiser- Northern California
state: California
city: Vista
country: United States
facility: San Diego Cancer Center
state: California
city: Fort Collins
country: United States
facility: Oncology Hematology Associates, Paudre Calley Cancer Ctr.
state: Colorado
city: Miami
country: United States
facility: University of Miami-Sylvester Comprehensive Cancer Center
state: Florida
city: Sarasota
country: United States
facility: Oncology Hematology Consultants
state: Florida
city: Atlanta
country: United States
facility: Georgia Urology, P.A.
state: Georgia
city: Tucker
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical
state: Illinois
city: Skokie
country: United States
facility: Midwest Cancer Research Group
state: Illinois
city: Davenport
country: United States
facility: Urologic Associates- P.C.
state: Iowa
city: Crestview HIlls
country: United States
facility: Oncology Hematology Care
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Hospital and Clinic
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rockville
country: United States
facility: Associates in Oncology Hematology P.C.
state: Maryland
city: St. Louis Park
country: United States
facility: Metro Minnesota CCOP
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Omaha
country: United States
facility: Univ. of Nebraska Medical Center/VA Hospital
state: Nebraska
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
city: Bronx
country: United States
facility: Lincoln Medical & Mental Health Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Nyack
country: United States
facility: Union State Bank Cancer Center
state: New York
city: Cary
country: United States
facility: Raleigh Hematology Oncology Clinic
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation, Taussig Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Oncology Hematology, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
city: Portland
country: United States
facility: NW Kaiser Permanente Portland
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina - Hollings Cancer Center
state: South Carolina
city: Chattanooga
country: United States
facility: University Oncology/ Hematology Associates
state: Tennessee
city: Memphis
country: United States
facility: Boston Baskin Cancer Group
state: Tennessee
city: Austin
country: United States
facility: Professional Quality Research
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Fort Worth
country: United States
facility: Texas Cancer Care
state: Texas
city: Ft. Worth
country: United States
facility: Urology Associates of North Texas
state: Texas
city: Plano
country: United States
facility: North Texas Regional Cancer Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington Cancer Care
state: Washington
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Cancer Center
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto-Sunnybrook Regional Cancer Center
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital, University Health Network
state: Ontario
city: Montreal
country: Canada
facility: CHUM / Notre-Dame Hospital
state: Quebec
city: Quebec
country: Canada
facility: Centre hospitalier universitaire de Quebec, Hotel-Dieu de Quebec
Study officials:
affiliation: Oregon Health and Science University
name: Tomasz Beer, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Beer 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.