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AzTrials

Prostate CancerPhase 3NCT00273338

DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])

A Phase 3 study testing calcitriol and docetaxel in people with Prostate Cancer, run by Novacea at 222 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The primary objective of this study is: To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer The secondary objectives of this study are: To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood… 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
1,200 participants
Where
222 sitesin 9 countries
Study dates
Jan 2006to Nov 2007
Phase
Phase 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

Who may be able to join

  • Histopathologically or cytologically proven adenocarcinoma of the prostate
  • Documented metastatic prostate adenocarcinoma
  • Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 2
  • Adequate hematologic, renal and hepatic function
  • Life expectancy >= 3 months

Who cannot join

  • Prior chemotherapy, except estramustine
  • Prior chemotherapy with docetaxel
  • Prior isotope therapy (e.g., strontium-89, samarium-153, etc.)
  • One or more contraindications to the use of corticosteroids
  • History of cancer-related hypercalcemia

Trial locations and contacts

222 sites in 9 countries.

222 sites in 9 countries

United States159 sites

  • Pasco Hernando Oncology Associates, P.A.

    14529 Cortez Blvd., Florida, 34613

  • Texas Cancer Center-Abilene

    Abilene, Texas, 79606-5208

  • Phoebe Cancer Center

    Albany, Georgia, 31701

  • Hematology Oncology Life Center

    Alexandria, Louisiana, 71301

  • Texas Oncology, PA

    Amarillo, Texas, 79106

  • Alaska Clinical Research Center

    Anchorage, Alaska, 99508

  • Texas Cancer Center

    Arlington, Texas, 76014

  • Urology Associates of North Texas (UANT)

    Arlington, Texas, 76017

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • Peachtree Hematology-Oncology Consultants, PC

    Atlanta, Georgia, 30309

  • Atlanta Cancer Care

    Atlanta, Georgia, 30342

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • St. Agnes Health System

    Baltimore, Maryland, 21229

  • MamieMcFaddin Ward Cancer Center

    Beaumont, Texas, 77702-1449

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211-1850

  • Birmingham Hematology & Oncology Associates, LLC

    Birmingham, Alabama, 35223

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Highline Medical Oncology

    Burien, Washington, 98166

  • Aultman Hospital

    Canton, Ohio, 44710

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Raleigh Hematology Oncology Associates

    Cary, North Carolina, 27511

  • Iowa Cancer Care

    Cedar Rapids, Iowa, 52403

  • Charleston Hematology Oncology PA

    Charleston, South Carolina, 29403

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Medical University Of South Carolina

    Charleston, South Carolina, 29425

  • Chattanooga Oncology & Hematology Assoc.

    Chattanooga, Tennessee, TN

  • Hematology Oncology Associates of Illinois

    Chicago, Illinois, 60611

  • Midwest Prostate & Urology Health Center

    Chicago, Illinois, 60640

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80909

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • University of Missouri, Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • Mid Ohio Oncology/Hematology, Inc.

    Columbus, Ohio, 43213

  • Texas Cancer Center ar Medical City

    Dallas, Texas, 75230-2510

  • Center for Oncology Research and Treatment, PA

    Dallas, Texas, 75230

  • Texas Oncology, P.A.

    Dallas, Texas, 75231-4400

  • The Texas Cancer Center

    Dallas, Texas, 75237

  • North Broward Medical Center

    Deerfield Beach, Florida, 33064

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Consultants in Medical Oncology & Hematology

    Drexel Hill, Pennsylvania, 19026

  • Hematology & Oncology Associates of Northeastern PA

    Dunmore, Pennsylvania, 18512

  • Puget Sound Cancer Centers

    Edmonds, Washington, 98026

  • El Paso Cancer Treatment Center-East

    El Paso, Texas, 79915

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401-8122

  • Fairfax Northern Virginia Hematology OnCology, PC

    Fairfax, Virginia, 22031

  • Dakota Cancer Institute

    Fargo, North Dakota, 58103

  • Carolina Cancer Management, Inc.

    Fayetteville, North Carolina, 28304

  • Broward Oncology Associates

    Fort Lauderdale, Florida, 33308

  • Michael and Dianne Bienes Comprehensive Cancer Center

    Fort Lauderdale, Florida, 33308

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • The Center for Cancer & Blood Disorders

    Fort Worth, Texas, 76104

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • Gainesville Hematology Oncology Associates

    Gainesville, Florida, 32605

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32611

  • Northeast GA Medical Center

    Gainesville, Georgia, 30501

  • Texas Oncology, P.A.

    Garland, Texas, 75042-5788

  • The Jones Clinic

    Germantown, Tennessee, 38138

  • Cancer Centers of the Carolina

    Greenville, South Carolina, 29615

  • South Carolina Cancer Specialists

    Hilton Head Island, South Carolina, 29926

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Texas Oncology, P.A.

    Houston, Texas, 77024

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46227

  • Integrated Community Oncology Network

    Jacksonville, Florida, 32256

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Dayton Oncology & Hematology, P.A.

    Kettering, Ohio, 45409

  • Medical Oncology Associates of Wyoming Valley, PC

    Kingston, Pennsylvania, 18704

  • St. Mary Medical Center

    Langhorne, Pennsylvania, 19047

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • Lake Vista Cancer Center

    Lewisville, Texas, 75067

  • Nebraska Hematology-Oncology, PC

    Lincoln, Nebraska, 68506

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Texas Oncology, P.A.

    Longview, Texas, 75601

  • The Angeles Clinic and Research Institute, Inc.

    Los Angeles, California, 90025

  • UCLA department of Urology

    Los Angeles, California, 90095-1738

  • Southwest Cancer Treatment and Research Center

    Lubbock, Texas, 79415

  • Veterans Affairs Northern California Health Care System

    Martinez, California, 94553

  • Mercy Medical Center, North Iowa

    Mason City, Iowa, 50401

  • South Texas Cancer Center - McAllen

    McAllen, Texas, 78503

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Sylvester Comprehensive Cancer Center, U of Miami

    Miami, Florida, 33136

  • Allison Cancer Center

    Midland, Texas, 79701-5946

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • MN Cooperative Group Outreach Prg.

    Minneapolis, Minnesota, 55407

  • Sutter Gould Medical Foundation

    Modesto, California, 95355

  • Monterey Bay Oncology

    Monterey, California, 93940

  • Medical Consultants, PC c/o Ball Cancer Center

    Muncie, Indiana, 47303

  • Northwest Alabama Cancer Center

    Muscle Shoals, Alabama, 35661

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Cancer Care Network of South Texas, HOAST

    New Braunfels, Texas, 78131

  • Hematology Oncology Associates of

    New City, New York, 10956

  • Pasco Hernando Oncology Associates P.A.

    New Port Richey, Florida, 34652

  • Florida Cancer Institute

    New Port Richey, Florida, 34655

  • Memorial Sloan-Kett

    New York, New York, 10021

  • UMDNJ-Newark

    Newark, New Jersey, 07101

  • Cancer Care & Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Innovative Medical Research of South Florida Inc.

    North Miami Beach, Florida, 33179

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Cancer Centers of Florida, P.A.

    Ocoee, Florida, 34761

  • West Texas Cancer Center

    Odessa, Texas, 79761

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 73112

  • Nebraska Methodist Hospital - Oncology Research Dept

    Omaha, Nebraska, 68144

  • Comprehensive Cancer Center at

    Palm Springs, California, 92262

  • The Valley Hospital

    Paramus, New Jersey, 07652

  • Paris Regional Cancer Center

    Paris, Texas, 75460-5004

  • Oncology Specialists

    Park Ridge, Illinois, 60068

  • Greater Philadelphia Cancer

    Philadelphia, Pennsylvania, 19114

  • Hematology Associates - AOA

    Phoenix, Arizona, 85012

  • Univeristy of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Pottsville Cancer Care

    Pottsville, Pennsylvania, 17901

  • Interlakes Foundation Inc.

    Rochester, New York, 14623

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Swedish American Regional Cancer Center

    Rockford, Illinois, 61104

  • Sutter Cancer Center

    Sacramento, California, 95816

  • UCD Cancer Center-Clinical Trials

    Sacramento, California, 95817

  • St. Joseph Oncology, Inc.

    Saint Joseph, Missouri, 64507

  • Park Nicollet Institute

    Saint Louis Park, Minnesota, 55416

  • Oncology & Hematology Associates of Southwest Virginia, Inc.

    Salem, Virginia, 24153

  • South Texas Oncology and Hematology, PA

    San Antonio, Texas, 78229

  • InVisions Consultants LLC

    San Antonio, Texas, 78233

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • California Pacific Medical Center

    San Francisco, California, 94115

  • New Mexico Cancer Care Associates

    Sante Fe, New Mexico, 87505

  • Guthrie Clinic

    Sayre, Pennsylvania, 18840

  • Maine Center for Cancer Medicine & Blood Disorders

    Scarborough, Maine, 04074

  • Horizon's West Medical Group

    Scottsbluff, Nebraska, 69361

  • Premiere Oncology of Arizona

    Scottsdale, Arizona, 85260

  • University of Washington

    Seattle, Washington, 98109

  • Puget Sound Cancer Centers

    Seattle, Washington, 98133

  • Northern Arizona Hematology & Oncology Associates, AOA

    Sedona, Arizona, 86336

  • Texas Cancer Center- Sherman

    Sherman, Texas, 75090-0504

  • Siouxland Hematology-Oncology Associates

    Sioux City, Iowa, 51101

  • Hematology Oncology Associates of Illinois, L.L.C

    Skokie, Illinois, 60077

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • Stanford University

    Stanford, California, 94305

  • Staten Island Urological Research, PC

    Staten Island, New York, 10304

  • Texas Oncology Cancer Center-Sugar Land

    Sugar Land, Texas, 77479

  • Overlook Oncology Center

    Summit, New Jersey, 07901

  • Hope Center

    Terre Haute, Indiana, 47802

  • AYS Urology

    Trinity, Florida, 34655

  • Georgia Cancer Specialist

    Tucker, Georgia, 30084

  • Southern Arizona VA Healthcare System

    Tucson, Arizona, 85723

  • U of Arizona / Arizona Cancer Center

    Tucson, Arizona, 85724

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • South Georgia Medical Center

    Valdosta, Georgia, 31602

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684

  • Medical Center of Vincennes

    Vincennes, Indiana, 47591

  • Texas Oncology

    Waco, Texas, 76022

  • Texas Oncology Cancer Care and Research Center

    Waco, Texas, 76712

  • Georgetown University Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Piedmont Hematology Oncology Associates, PLLC

    Winston-Salem, North Carolina, 27103

  • Yakima Valley Memorial Hospital/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

Germany28 sites

  • Gemeinschaftspraxis für Hämatologie & Onkologie

    Augsburg, 86150

  • Facharzt f. Urologie

    Bad Schwartau, 23611

  • Urologische Praxis

    Bautzen, 02625

  • Universitatsmedizin Charité

    Berlin, 10117

  • Klinik am Urban

    Berlin, 10967

  • Universitätsmedizin Charité Campus Benjamin Franklin

    Berlin, 12200

  • Urologische Praxis

    Berlin

  • Städtisches Klinikum Braunschweig

    Braunschweig, 38126

  • Universitätsklinikum Köln

    Cologne, 50931

  • Facharzt f. Urologie

    Cottbus, 03046

  • Urologische Klinik

    Dresden, 01307

  • Universitäsklinikum Düsseldorf

    Düsseldorf, 40225

  • Urologische Klinik der Universitätsklink Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Essen

    Essen

  • Klinikum Fulda, Urologische Klinik

    Fulda, 36043

  • Urologische Praxis

    Hagenow

  • Urologische Gemeinschaftspraxis

    Hamburg, 22399

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Nationales Centrum für Tumorerkrankungen

    Heidelberg, 69120

  • Universitätsklinikum Homburg/Saar

    Homburg

  • Klinikum Kassel GmbH

    Kassel, 34125

  • Gemeinschaftspraxis für Urologie

    Kirchheim/Teck, 73230

  • Gesellschaft f. klinische Studien und Urologisches Gesundheitszentrum

    Leipzig

  • Oberarzt d. Urolog. Abteilung

    München, 81675

  • Obearzt der Urologischen Klinik, Universitätsklinik Münster

    Münster, 48149

  • Praxisgemeinschaft für Onkologie und Urologie

    Wilhelmshaven, 26389

  • Gemeinschaftspraxis f. Urologie

    Wuppertal, 42103

  • Urologische Praxis

    Zwickau

Other trials in Germany

Canada18 sites

  • Tom Baker Cancer Center-Medical Oncology

    Calgary, Alberta, T2N4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Regional Cancer Program de l'Hopital Regional de Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Centre for Clinical Research Cancer Care Program

    Halifax, Nova Scotia, B3H 1V7

  • Jaravinski Cancer Centre Hamilton Health Services

    Hamilton, Ontario, L8V 5C2

  • BCCA-Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Cancer Centre of Southeastern Ontario

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • The Moncton Hospital (SERHA)

    Moncton, New Brunswick, E1C 6Z8

  • Dr. Leon Richard Oncology Center

    Moncton, New Brunswick, EIC8X3

  • McGill University

    Montreal, Quebec, H2W 1S6

  • The Ottawa Hospital Regional Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • BCCA-Vancouver

    Vancouver, British Columbia, V5Z4E6

  • British Columbia Cancer Agency - Vancouver Island Centre

    Victoria, British Columbia, V8R 6V5

  • Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E0V9

Other trials in Canada

Romania5 sites

  • Cabinetul de Urologie

    Arad, 310175

  • Policlinica de diagnostic rapid

    Brasov, 500366

  • Institutul Oncologic Bucuresti

    Bucharest

  • Euro S.R.L.

    Cluj-Napoca, 400046

  • ProVita 2000

    Constanța, 900635

Other trials in Romania

Hungary4 sites

  • IRM Center Hospital and Institutes, II.Department of Oncology

    Budapest, 1071

  • Uzsoki Hospital of the Local Authority of Budapest, Oncoradiology

    Budapest, H-1145

  • University of Debrecen, Medical and Health Science Center, Department of Oncology

    Debrecen, H4032

  • University of Szeged, Szent-Györgyi Albert Medical and Pharmacist Science Center, Clinic of Oncotherapy

    Szeged

Other trials in Hungary

Czechia3 sites

  • Institute of Radiation Oncology of Teaching Hospital Na Bulovce

    Prague, 180 81

  • Department of Radiation and Oncology of Teaching Hospital Motol

    Prague

  • Teaching Hospital Kralovske Vinohrady

    Prague

Other trials in Czechia

Slovakia3 sites

  • Theaching Hospital of F.D. Roosevelt

    Banská Bystrica, 97517

  • Faculty Hospital Martin

    Martin, 03659

  • Faculty Hospital of J. A. Reiman

    Prešov

Other trials in Slovakia

Puerto Rico1 site

  • San Juan VA Medical Center, Reseach Dept

    San Juan, 00921

Other trials in Puerto Rico

Serbia and Montenegro1 site

  • Clinical Center Niš - Clinic of Urology

    Belgrade, 18000

Other trials in Serbia and Montenegro

About this study

Official title: A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)

The primary objective of this study is:

  • To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer

The secondary objectives of this study are:

  • To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots)
  • To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures)
  • A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.
Conditions
Prostate Cancer
Being tested
calcitriol, docetaxel
Keywords
Androgen-independent Prostate Cancer (AIPC), Prostate Cancer, DN-101, calcitriol, Taxotere, docetaxel
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2006 (estimated)
  2. Study startJan 2006
  3. Study completionNov 2007

Why it stopped: DSMB

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00273338
Sponsor's protocol ID
011-007
Status last verified
Nov 2007
First submitted
14 Dec 2005
Last updated
6 Nov 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing calcitriol and docetaxel in people with Prostate Cancer, run by Novacea at 222 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. 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: stopped early, as of the sponsor's last update on 6 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 222 sites in United States, Germany, Canada, Romania, Hungary and 4 more countries. 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 phase mean?

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?

The study was stopped early (reason given: DSMB). 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 NCT00273338.

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 6 Nov 2007.

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