Prostate CancerPhase 2/3NCT00043576
ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere
A Phase 2/3 study testing calcitriol and docetaxel in people with Prostate Cancer, run by Novacea at 62 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- calcitriol and docetaxel
- How many people
- 250 participants
- Where
- 62 sitesin 2 countries
- Study dates
- Aug 2002to Dec 2005
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
62 sites in 2 countries.
62 sites in 2 countries
United States52 sites
Georgia Urology, P.A.
Atlanta, Georgia, 30342
Professional Quality Research
Austin, Texas, 78756
Johns Hopkins University
Baltimore, Maryland, 21232
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
Roswell Park Cancer Institute
Buffalo, New York, 14263
Raleigh Hematology Oncology Clinic
Cary, North Carolina, 27511
Charleston Hematology Oncology
Charleston, South Carolina, 29403
Medical University of South Carolina - Hollings Cancer Center
Charleston, South Carolina, 29425
University Oncology/ Hematology Associates
Chattanooga, Tennessee, 37403
The Cleveland Clinic Foundation, Taussig Cancer Center
Cleveland, Ohio, 44195
Missouri Cancer Associates
Columbia, Missouri, 65201
Mid Ohio Oncology Hematology, Inc.
Columbus, Ohio, 43222
Oncology Hematology Care
Crestview Hills, Kentucky, 41017
Texas Oncology, P.A.
Dallas, Texas, 75246
Urologic Associates- P.C.
Davenport, Iowa, 52807
Oncology Hematology Associates, Paudre Calley Cancer Ctr.
Fort Collins, Colorado, 80528
Texas Cancer Care
Fort Worth, Texas, 76104
Urology Associates of North Texas
Fort Worth, Texas, 76104
California Cancer Care
Greenbrae, California, 94904
University of Arkansas for Medical Sciences / Central AR VA
Little Rock, Arkansas, 72205
Tower Hematology Oncology Medical Group
Los Angeles, California, 90048
Prostate Oncology Specialist/Pacific Clinical Research
Marina del Rey, California, 90292
Loyola University Medical
Maywood, Illinois, 60153
Boston Baskin Cancer Group
Memphis, Tennessee, 38104
University of Miami-Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Montgomery Cancer Center
Montgomery, Alabama, 36106
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112
Columbia Presbyterian Medical Center
New York, New York, 10032
Union State Bank Cancer Center
Nyack, New York, 10960
Univ. of Nebraska Medical Center/VA Hospital
Omaha, Nebraska, 68198
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
North Texas Regional Cancer Center
Plano, Texas, 75075
Oregon Health & Sciences University
Portland, Oregon, 97201
NW Kaiser Permanente Portland
Portland, Oregon, 97227
Associates in Oncology Hematology P.C.
Rockville, Maryland, 20850
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Metro Minnesota CCOP
Saint Louis Park, Minnesota, 55416
Southern California Permanente Medical Group
San Diego, California, 92120
Sharp Healthcare
San Diego, California, 92121
Pacific Hematology Oncology Associates
San Francisco, California, 94115
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505
Oncology Hematology Consultants
Sarasota, Florida, 34239
Arizona Cancer Center- Scottsdale
Scottsdale, Arizona, 85258
University of Washington Cancer Care
Seattle, Washington, 98109
Midwest Cancer Research Group
Skokie, Illinois, 60077
Lincoln Medical & Mental Health Center
The Bronx, New York, 10459
Georgia Cancer Specialists
Tucker, Georgia, 30084
Arizona Cancer Center/Southern Arizona VA HCS
Tucson, Arizona, 85723
Arizona Cancer Center- Tucson
Tucson, Arizona, 85724
Tyler Cancer Center
Tyler, Texas, 75702
Kaiser- Northern California
Vallejo, California, 94589
San Diego Cancer Center
Vista, California, 92083
Canada10 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
London Regional Cancer Centre
London, Ontario, N6A 4L6
CHUM / Notre-Dame Hospital
Montreal, Quebec, H2L 4M1
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Centre hospitalier universitaire de Quebec, Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6
Toronto-Sunnybrook Regional Cancer Center
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital, University Health Network
Toronto, Ontario, M5G 2M9
Vancouver Cancer Center
Vancouver, British Columbia, V5Z 4E6
CancerCare Manitoba
Winnipeg, Manitoba, R3E OV9
About this study
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)
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- calcitriol, docetaxel
- Keywords
- Prostate Cancer, Androgen Independent Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcitriolDrug
docetaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2002 (estimated)
- Study startAug 2002
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Novacea
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aventis Pharmaceuticals
- Investigators
- Tomasz Beer, MD, Study chair, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043576
- Sponsor's protocol ID
- DN101-002
- Other IDs
- ASCENT Trial
- Status last verified
- Feb 2005
- First submitted
- 9 Aug 2002
- Last updated
- 12 Mar 2009
- Results posted
- No
Publications
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.
PubMed 11413535Beer 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.
PubMed 12506180
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00043576
- Acronym / sponsor ID
- DN101-002
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Androgen Independent Prostate Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants
- Lead sponsor
- NovaceaIndustry (pharma, biotech, devices)
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Aug 2002
- Study completion
- Dec 2005
- First posted
- 13 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcitriol | Drug | – |
| docetaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2009.
- Background: PubMed 11413535Beer 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.
- Background: PubMed 12506180Beer 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.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Beer, MD study chair
Oregon Health and Science University
62 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing calcitriol and docetaxel in people with Prostate Cancer, run by Novacea at 62 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00043576, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2009.