A Randomized Phase II Study of Mitoxantrone vs. Mitoxantrone With Cetuximab in Metastatic Androgen Independent Prostate Cancer (AIPC) Previously Treated With Docetaxel-based Chemotherapy
This is a nonblinded, randomized phase II study to determine the activity of Novantrone
(mitoxantrone) with or without Erbitux (cetuximab) in patients with androgen independent
prostate cancer (AIPC) who have been treated previously with docetaxel chemotherapy. The
Novantrone (mitoxantrone)-only treatment arm will serve as a concurrent control arm to aid
in the determination of the benefit of the Novantrone (mitoxantrone)-Erbitux (cetuximab)
combination in this setting.
Patients will be randomly assigned 2:1 to 1 of 2 treatment arms; 93 patients in Arm 1 and 47
patients in Arm 2. A balanced randomization procedure will be performed utilizing a code
list that will be developed prior to the study opening. Because the patients will be
stratified by performance status (ECOG 0 and 1 vs. ECOG 2), the list will be developed to
ensure a balance between the 2 treatment arms.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the time to progression produced by the combination of Novantrone (mitoxantrone) and Erbitux (cetuximab) versus Novantrone alone in metastatic AIPC patients previously treated with docetaxel-based chemotherapy.
approximately 2 years
No
Mark T. Fleming, MD
Principal Investigator
Virginia Oncology Associates/US Oncology
United States: Institutional Review Board
06-118
NCT00661492
May 2008
May 2010
Name | Location |
---|---|
Texas Oncology, P.A. | Dallas, Texas 75246 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
Ocala Oncology Center | Ocala, Florida 34474 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Tyler Cancer Center | Tyler, Texas 75702 |
Oregon Health & Science University | Portland, Oregon 97201 |
Hope Center | Terre Haute, Indiana 47809 |
Willamette Valley Cancer Center | Eugene, Oregon 97401-8122 |
St. Joseph Oncology, Inc. | Saint Joseph, Missouri 64506 |
Cancer Centers of Florida, P.A. | Orlando, Florida |
Rocky Mountain Cancer Center-Midtown | Denver, Colorado 80218 |
Northwest Cancer Specialists-Vancouver | Vancouver, Washington 98684 |
Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
Minnesota Oncology Hematology, P.A. | Minneapolis, Minnesota 55407 |
Texas Cancer Center at Medical City | Dallas, Texas 75230 |
Allison Cancer Center | Midland, Texas 79701 |
Highline Medical Oncology | Burien, Washington 98166 |
Hematology Oncology Associates | Phoenix, Arizona 85012 |
Greater Dayton Cancer Center | Kettering, Ohio 45409 |
Texas Cancer Center | Abilene, Texas 79606 |
Mamie McFaddin Ward Cancer Center | Beaumont, Texas 77702 |
Longview Cancer Center | Longview, Texas 75601 |
Texas Cancer Center of Mesquite | Mesquite, Texas 75150 |
Onc and Hem Associates of SW VA, Inc. | Salem, Virginia 24153 |
Texas Oncology, P.A | Arlington, Texas 76012 |
South Texas Cancer Center - McAllen | McAllen, Texas 78503-1298 |
Paris Regional Cancer Center | Paris, Texas 75460 |
Texas Cancer Center - Sherman | Sherman, Texas 75090-0504 |
Cancer Care & Hematology Specialists of Chicagoland | Niles, Illinois 60714 |
Texas Oncology - Central Austin Cancer Center | Austin, Texas 78731 |
Northern AZ Hematology & Oncology Assoc | Sedona, Arizona 86336 |
Melbourne Internal Medicine Associates | Melbourne, Florida 32901 |
NH Oncology-Hematology PA | Hooksett, New Hampshire 03106 |
Interlakes Oncology Hematology, PC | Rochester, New York 14623 |
El Paso Cancer Treatment Ctr | El Paso, Texas 79915 |
Texas Oncology Cancer Center-Sugar Land | Sugar Land, Texas 77479 |
Puget Sound Cancer Center-Seattle | Seattle, Washington 98133 |
Cancer Care Northwest-South | Spokane, Washington 99202 |
Yakima Valley Mem Hosp/North Star Lodge | Yakima, Washington 98902 |
Fairfax Northern VA Hem-Onc PC | Fairfax, Virginia 22031 |
Puget Sound Cancer Center-Edmonds | Edmonds, Washington 98026 |
Cancer Centers of North Carolina | Raleigh, North Carolina 27607 |
Florida Cancer Institute - New Hope | New Port Richey, Florida 34655 |
Methodist Charlton Cancer Ctr. | Dallas, Texas 75237 |
Columbia Basin Hematology and Oncology | Kennewick, Washington 99336 |
Texas Oncology - Odessa | Odessa, Texas 79761 |
Hematology-Oncology Associates of NNJ, P | Morristown, New Jersey 07960 |
Albany Medical Cancer Center | Albany, New York 12208 |
Texas Oncology, P.A. -Amarillo | Amarillo, Texas 79106 |