ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere

March 10, 2009 updated by: Novacea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

250

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1R 2J6
        • Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Vancouver Cancer Center
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E OV9
        • CancerCare Manitoba
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto-Sunnybrook Regional Cancer Center
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital, University Health Network
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • CHUM / Notre-Dame Hospital
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36106
        • Montgomery Cancer Center
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Arizona Cancer Center- Scottsdale
      • Tucson, Arizona, United States, 85723
        • Arizona Cancer Center/Southern Arizona VA HCS
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center- Tucson
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences / Central AR VA
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • Greenbrae, California, United States, 94904
        • California Cancer Care
      • Los Angeles, California, United States, 90048
        • Tower Hematology Oncology Medical Group
      • Marina Del Rey, California, United States, 90292
        • Prostate Oncology Specialist/Pacific Clinical Research
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Center
      • San Diego, California, United States, 92120
        • Southern California Permanente Medical Group
      • San Diego, California, United States, 92121
        • Sharp HealthCare
      • San Francisco, California, United States, 94115
        • Pacific Hematology Oncology Associates
      • Vallejo, California, United States, 94589
        • Kaiser- Northern California
      • Vista, California, United States, 92083
        • San Diego Cancer Center
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Oncology Hematology Associates, Paudre Calley Cancer Ctr.
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami-Sylvester Comprehensive Cancer Center
      • Sarasota, Florida, United States, 34239
        • Oncology Hematology Consultants
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Georgia Urology, P.A.
      • Tucker, Georgia, United States, 30084
        • Georgia Cancer Specialists
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical
      • Skokie, Illinois, United States, 60077
        • Midwest Cancer Research Group
    • Iowa
      • Davenport, Iowa, United States, 52807
        • Urologic Associates- P.C.
    • Kentucky
      • Crestview HIlls, Kentucky, United States, 41017
        • Oncology Hematology Care
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Hospital and Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21232
        • Johns Hopkins University
      • Rockville, Maryland, United States, 20850
        • Associates in Oncology Hematology P.C.
    • Minnesota
      • St. Louis Park, Minnesota, United States, 55416
        • Metro Minnesota CCOP
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Cancer Associates
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Univ. of Nebraska Medical Center/VA Hospital
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • New Mexico Cancer Care Associates
    • New York
      • Bronx, New York, United States, 10459
        • Lincoln Medical & Mental Health Center
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10032
        • Columbia Presbyterian Medical Center
      • Nyack, New York, United States, 10960
        • Union State Bank Cancer Center
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Raleigh Hematology Oncology Clinic
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation, Taussig Cancer Center
      • Columbus, Ohio, United States, 43222
        • Mid Ohio Oncology Hematology, Inc.
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health & Sciences University
      • Portland, Oregon, United States, 97227
        • NW Kaiser Permanente Portland
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University Of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina - Hollings Cancer Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • University Oncology/ Hematology Associates
      • Memphis, Tennessee, United States, 38104
        • Boston Baskin Cancer Group
    • Texas
      • Austin, Texas, United States, 78756
        • Professional Quality Research
      • Dallas, Texas, United States, 75246
        • Texas Oncology, P.A.
      • Fort Worth, Texas, United States, 76104
        • Texas Cancer Care
      • Ft. Worth, Texas, United States, 76104
        • Urology Associates of North Texas
      • Plano, Texas, United States, 75075
        • North Texas Regional Cancer Center
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington Cancer Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novacea

Collaborators

Aventis Pharmaceuticals

Investigators

  • Study Chair: Tomasz Beer, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

August 9, 2002

First Submitted That Met QC Criteria

August 12, 2002

First Posted (ESTIMATE)

August 13, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 10, 2009

Last Verified

February 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DN101-002
  • ASCENT Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on docetaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe