ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere

Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00043576
• Other study ID #: DN101-002
• Secondary ID: ASCENT Trial
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: August 9, 2002
• Last updated: March 10, 2009
• Start date: August 2002
• Est. completion date: December 2005

Study information

• Verified date: February 2005
• Source: Novacea
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

• 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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• calcitriol

• docetaxel

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Novacea	Aventis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

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. — View 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. — View Citation

Beer, T.M., Eilers, K.M., Garzotto, M., Lowe, B.A., Henner, W.D. Androgen-independent prostate cancer (AIPC) treatment with weekly high dose calcitriol and docetaxel. ASCO Abstract #707, v.21, p. 177a, 2002.