search
Back to results

ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
calcitriol
docetaxel
Sponsored by
Novacea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Androgen Independent Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Montgomery Cancer Center
  • Arizona Cancer Center- Scottsdale
  • Arizona Cancer Center/Southern Arizona VA HCS
  • Arizona Cancer Center- Tucson
  • University of Arkansas for Medical Sciences / Central AR VA
  • Alta Bates Comprehensive Cancer Center
  • California Cancer Care
  • Tower Hematology Oncology Medical Group
  • Prostate Oncology Specialist/Pacific Clinical Research
  • UC Davis Comprehensive Cancer Center
  • Southern California Permanente Medical Group
  • Sharp Healthcare
  • Pacific Hematology Oncology Associates
  • Kaiser- Northern California
  • San Diego Cancer Center
  • Oncology Hematology Associates, Paudre Calley Cancer Ctr.
  • University of Miami-Sylvester Comprehensive Cancer Center
  • Oncology Hematology Consultants
  • Georgia Urology, P.A.
  • Georgia Cancer Specialists
  • Loyola University Medical
  • Midwest Cancer Research Group
  • Urologic Associates- P.C.
  • Oncology Hematology Care
  • Tulane University Hospital and Clinic
  • Johns Hopkins University
  • Associates in Oncology Hematology P.C.
  • Metro Minnesota CCOP
  • Missouri Cancer Associates
  • Univ. of Nebraska Medical Center/VA Hospital
  • New Mexico Cancer Care Associates
  • Lincoln Medical & Mental Health Center
  • Roswell Park Cancer Institute
  • Columbia Presbyterian Medical Center
  • Union State Bank Cancer Center
  • Raleigh Hematology Oncology Clinic
  • The Cleveland Clinic Foundation, Taussig Cancer Center
  • Mid Ohio Oncology Hematology, Inc.
  • Oregon Health & Sciences University
  • NW Kaiser Permanente Portland
  • University of Pittsburgh
  • Charleston Hematology Oncology
  • Medical University of South Carolina - Hollings Cancer Center
  • University Oncology/ Hematology Associates
  • Boston Baskin Cancer Group
  • Professional Quality Research
  • Texas Oncology, P.A.
  • Texas Cancer Care
  • Urology Associates of North Texas
  • North Texas Regional Cancer Center
  • Tyler Cancer Center
  • University of Washington Cancer Care
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • Vancouver Cancer Center
  • CancerCare Manitoba
  • London Regional Cancer Centre
  • Ottawa Regional Cancer Centre
  • Toronto-Sunnybrook Regional Cancer Center
  • Princess Margaret Hospital, University Health Network
  • CHUM / Notre-Dame Hospital
  • Centre hospitalier universitaire de Quebec, Hotel-Dieu de Quebec

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 9, 2002
Last Updated
March 10, 2009
Sponsor
Novacea
Collaborators
Aventis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00043576
Brief Title
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

2. Study Status

Record Verification Date
February 2005
Overall Recruitment Status
Unknown status
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novacea
Collaborators
Aventis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Androgen Independent Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
calcitriol
Intervention Type
Drug
Intervention Name(s)
docetaxel

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Beer, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Study Chair
Facility Information:
Facility Name
Montgomery Cancer Center
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Arizona Cancer Center- Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Arizona Cancer Center/Southern Arizona VA HCS
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Arizona Cancer Center- Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arkansas for Medical Sciences / Central AR VA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
California Cancer Care
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Tower Hematology Oncology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Prostate Oncology Specialist/Pacific Clinical Research
City
Marina Del Rey
State/Province
California
ZIP/Postal Code
90292
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Southern California Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Sharp Healthcare
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser- Northern California
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
San Diego Cancer Center
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Oncology Hematology Associates, Paudre Calley Cancer Ctr.
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
University of Miami-Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Oncology Hematology Consultants
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Georgia Urology, P.A.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Georgia Cancer Specialists
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
Loyola University Medical
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Midwest Cancer Research Group
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Urologic Associates- P.C.
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
Oncology Hematology Care
City
Crestview HIlls
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21232
Country
United States
Facility Name
Associates in Oncology Hematology P.C.
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Metro Minnesota CCOP
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Missouri Cancer Associates
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Univ. of Nebraska Medical Center/VA Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
New Mexico Cancer Care Associates
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Lincoln Medical & Mental Health Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10459
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Union State Bank Cancer Center
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Facility Name
Raleigh Hematology Oncology Clinic
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
The Cleveland Clinic Foundation, Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Mid Ohio Oncology Hematology, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Oregon Health & Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
NW Kaiser Permanente Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Charleston Hematology Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Medical University of South Carolina - Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University Oncology/ Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Boston Baskin Cancer Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Professional Quality Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Texas Oncology, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Cancer Care
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Urology Associates of North Texas
City
Ft. Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
North Texas Regional Cancer Center
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
University of Washington Cancer Care
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Vancouver Cancer Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E OV9
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Toronto-Sunnybrook Regional Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CHUM / Notre-Dame Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Centre hospitalier universitaire de Quebec, Hotel-Dieu de Quebec
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
11413535
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.
Results Reference
background
PubMed Identifier
12506180
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.
Results Reference
background

Learn more about this trial

ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere

We'll reach out to this number within 24 hrs