A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Howard I. Scher, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan Kettering Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
011-007
NCT ID:
NCT00273338
Start Date:
January 2006
Completion Date:
November 2007
Related Keywords:
- Prostate Cancer
- Androgen-independent Prostate Cancer (AIPC)
- Prostate Cancer
- DN-101
- calcitriol
- Taxotere
- docetaxel
- Prostatic Neoplasms
Name | Location |
|---|---|
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| Stanford University | Stanford, California 94305 |
| South Georgia Medical Center | Valdosta, Georgia 31603 |
| Texas Oncology, P.A. | Dallas, Texas 75246 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| University of Rochester Medical Center | Rochester, New York 14642 |
| Sutter Cancer Center | Sacramento, California 95816 |
| Dakota Cancer Institute | Fargo, North Dakota 58103-4940 |
| SUNY Downstate Medical Center | Brooklyn, New York 11203 |
| Virginia Oncology Associates | Newport News, Virginia 23606 |
| University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
| Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
| Siouxland Hematology-Oncology Associates | Sioux City, Iowa 51101 |
| Ocala Oncology Center | Ocala, Florida 34474 |
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Missouri Cancer Associates | Columbia, Missouri 65201 |
| University of Oklahoma | Oklahoma City, Oklahoma 73190 |
| Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
| Pacific Shores Medical Group | Long Beach, California 90813 |
| Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
| Sharp Memorial Hospital | San Diego, California 92123 |
| Sutter Gould Medical Foundation | Modesto, California 95353 |
| New Mexico Cancer Care Associates | Santa Fe, New Mexico 87505-7670 |
| University of Washington | Seattle, Washington 98195 |
| Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
| Atlanta Cancer Care | Atlanta, Georgia 30342 |
| Genesis Cancer Center | Hot Springs, Arkansas 71913 |
| Hope Center | Terre Haute, Indiana 47809 |
| Cancer Care Associates | Tulsa, Oklahoma 74136 |
| Willamette Valley Cancer Center | Eugene, Oregon 97401-8122 |
| Tower Cancer Research Foundation | Beverly Hills, California 90211 |
| St. Joseph Oncology, Inc. | Saint Joseph, Missouri 64506 |
| Henry Ford Health System | Detroit, Michigan 48202 |
| Georgia Cancer Specialist | Marietta, Georgia 30060 |
| Monterey Bay Oncology | Monterey, California 93940 |
| Charleston Cancer Center | Charleston, South Carolina 29406 |
| Broward Oncology Associates | Ft. Lauderdale, Florida 33308 |
| California Pacific Medical Center | San Francisco, California 94115 |
| Oncology Hematology Care, Inc. | Cincinnati, Ohio 45219 |
| Northeast Georgia Cancer Care, LLC | Athens, Georgia 30607 |
| The Cleveland Clinic Foundation | Cleveland, Ohio |
| Hematology Oncology Associates of Illinois | Skokie, Illinois 60077 |
| Cancer Centers of Florida, P.A. | Orlando, Florida |
| Texas Oncology | Dallas, Texas |
| Innovative Medical Research of South Florida Inc. | Miami Shores, Florida 33138 |
| Gabrail Cancer Center | Canton, Ohio 44718 |
| Maine Center for Cancer Medicine & Blood Disorders | Scarborough, Maine 04074 |
| Medical Center of Vincennes | Vincennes, Indiana 47591 |
| Texas Oncology, PA | Dallas, Texas 75246-2006 |
| Florida Cancer Institute | New Port Richey, Florida 34652 |
| Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
| Minnesota Oncology Hematology, P.A. | Minneapolis, Minnesota 55407 |
| Overlook Oncology Center | Summit, New Jersey 07901 |
| Medical Oncology Associates of Wyoming Valley, PC | Kingston, Pennsylvania 18704 |
| Allison Cancer Center | Midland, Texas 79701 |
| West Texas Cancer Center | Odessa, Texas 79761 |
| Southern Arizona VA Healthcare System | Tucson, Arizona 85723 |
| Frederick Memorial Hospital | Frederick, Maryland 21701 |
| Highline Medical Oncology | Burien, Washington 98166 |
| Consultants in Medical Oncology & Hematology | Drexel Hill, Pennsylvania 19026 |
| The Jones Clinic | Germantown, Tennessee 38138 |
| Mid Ohio Oncology/Hematology, Inc. | Columbus, Ohio 43213 |
| Horizon's West Medical Group | Scottsbluff, Nebraska 69361 |
| Northern Indiana Cancer Research Consortium | South Bend, Indiana |
| Alaska Clinical Research Center | Anchorage, Alaska 99508 |
| Staten Island Urological Research, PC | Staten Island, New York 10304 |
| Nevada Cancer Institute | Las Vegas, Nevada 89135 |
| Midwest Prostate & Urology Health Center | Chicago, Illinois 60640 |
| Piedmont Hematology Oncology Associates, PLLC | Winston-Salem, North Carolina |
| Northwest Cancer Specialists, P.C. | Vancouver, Washington |
| Texas Cancer Center | Abilene, Texas 79606 |
| Texas Oncology Cancer Center | Austin, Texas 78731 |
| The Texas Cancer Center | Dallas, Texas 75237 |
| Lake Vista Cancer Center | Lewisville, Texas 75067 |
| Texas Cancer Center of Mesquite | Mesquite, Texas 75150 |
| North Broward Medical Center | Dearfield Beach, Florida 33064-3596 |
| Raleigh Hematology Oncology Associates | Cary, North Carolina 27511 |
| Guthrie Clinic | Sayre, Pennsylvania 18840 |
| Center for Oncology Research and Treatment, PA | Dallas, Texas 75230 |
| Oncology Specialists | Park Ridge, Illinois 60068 |
| Puget Sound Cancer Centers | Edmonds, Washington 98026 |
| Maryland Oncology Hematology, P.A. | Columbia, Maryland 21044 |
| Dayton Oncology & Hematology, P.A. | Kettering, Ohio 45409 |
| South Texas Cancer Center - McAllen | McAllen, Texas 78503-1298 |
| Paris Regional Cancer Center | Paris, Texas 75460 |
| Fairfax Northern Virginia Hematology Oncology, PC | Fairfax, Virginia 22031 |
| Oncology & Hematology Associates of Southwest Virginia, Inc. | Salem, Virginia 24153 |
| Hematology Oncology Life Center | Alexandria, Louisiana 71301 |
| Medical Consultants, PC c/o Ball Cancer Center | Muncie, Indiana 47303 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| Northwest Alabama Cancer Center | Muscle Shoals, Alabama 35661 |
| Gainesville Hematology Oncology Associates | Gainesville, Florida 32605 |
| St. Mary Medical Center | Langhorne, Pennsylvania 19047 |
| South Carolina Cancer Specialists | Hilton Head Island, South Carolina 29925 |
| Park Nicollet Institute | St Louis Park, Minnesota 55416 |
| Nebraska Hematology-Oncology, PC | Lincoln, Nebraska 68506 |
| Phoebe Cancer Center | Albany, Georgia 31701 |
| Aultman Hospital | Canton, Ohio 44710 |
| Cancer Care & Hematology Specialists of Chicagoland | Niles, Illinois 60714 |
| Yakima Valley Memorial Hospital/North Star Lodge | Yakima, Washington 98902 |
| Texas Oncology Cancer Center-Sugar Land | Sugar Land, Texas 77479 |
| Premiere Oncology of Arizona | Scottsdale, Arizona 85260 |
| The Valley Hospital | Paramus, New Jersey 07652 |
| Birmingham Hematology & Oncology Associates, LLC | Birmingham, Alabama 35223 |
| Hematology Associates - AOA | Phoenix, Arizona 85012 |
| Northern Arizona Hematology & Oncology Associates, AOA | Sedona, Arizona 86336 |
| U of Arizona / Arizona Cancer Center | Tucson, Arizona 85724 |
| The Angeles Clinic and Research Institute, Inc. | Los Angeles, California 90025 |
| UCLA department of Urology | Los Angeles, California 90095-1738 |
| Veterans Affairs Northern California Health Care System | Martinez, California 94553 |
| Comprehensive Cancer Center at | Palm Springs, California 92262 |
| UCD Cancer Center-Clinical Trials | Sacramento, California 95817 |
| Georgetown University Lombardi Cancer Center | Washington, District of Columbia 20007 |
| Pasco Hernando Oncology Associates, P.A. | 14529 Cortez Blvd., Florida 34613 |
| Michael and Dianne Bienes Comprehensive Cancer Center | Ft. Lauderdale, Florida 33308 |
| Sylvester Comprehensive Cancer Center, U of Miami | Miami, Florida 33136 |
| Pasco Hernando Oncology Associates P.A. | New Port Richey, Florida 34652 |
| AYS Urology | Trinity, Florida 34655 |
| Peachtree Hematology-Oncology Consultants, PC | Atlanta, Georgia 30309 |
| Northeast GA Medical Center | Gainesville, Georgia 30501 |
| Swedish American Regional Cancer Center | Rockford, Illinois 61104 |
| Hematology Oncology Associates of Illinois, L.L.C | Skokie, Illinois 60077 |
| Iowa Cancer Care | Cedar Rapids, Iowa 52403 |
| Mercy Medical Center, North Iowa | Mason City, Iowa 50401 |
| St. Agnes Health System | Baltimore, Maryland 21229 |
| MN Cooperative Group Outreach Prg. | Minneapolis, Minnesota 55407 |
| University of Missouri, Ellis Fischel Cancer Center | Columbia, Missouri 65203 |
| Nebraska Methodist Hospital - Oncology Research Dept | Omaha, Nebraska 68144 |
| UMDNJ-Newark | Newark, New Jersey 07101 |
| Hematology Oncology Associates of | New City, New York 10956 |
| Memorial Sloan-Kett | New York, New York 10021 |
| Interlakes Foundation Inc. | Rochester, New York 14623 |
| Carolina Cancer Management, Inc. | Fayetteville, North Carolina 28304 |
| Hematology & Oncology Associates of Northeastern PA | Dunmore, Pennsylvania 18512 |
| Greater Philadelphia Cancer | Philadelphia, Pennsylvania 19114 |
| Univeristy of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15232 |
| Pottsville Cancer Care | Pottsville, Pennsylvania 17901 |
| Charleston Hematology Oncology PA | Charleston, South Carolina 29403 |
| Cancer Centers of the Carolina | Greenville, South Carolina 29615 |
| Chattanooga Oncology & Hematology Assoc. | Chattanooga, Tennessee TN |
| Texas Cancer Center-Abilene | Abilene, Texas 79606-5208 |
| Urology Associates of North Texas (UANT) | Arlington, Texas 76017 |
| MamieMcFaddin Ward Cancer Center | Beaumont, Texas 77702-1449 |
| Texas Cancer Center ar Medical City | Dallas, Texas 75230-2510 |
| El Paso Cancer Treatment Center-East | El Paso, Texas 79915 |
| The Center for Cancer & Blood Disorders | Fort Worth, Texas 76104 |
| Southwest Cancer Treatment and Research Center | Lubbock, Texas 79415 |
| Cancer Care Network of South Texas, HOAST | New Braunfels, Texas 78131 |
| InVisions Consultants LLC | San Antonio, Texas 78233 |
| South Texas Oncology and Hematology, PA | San Antonio, Texas 78229 |
| Texas Cancer Center- Sherman | Sherman, Texas 75090-0504 |
| Texas Oncology Cancer Care and Research Center | Waco, Texas 76712 |
