Spots Global Cancer Trial Database for Mitoxantrone ± Cetuximab 2nd Line Androgen Independent Prostate Cancer (AIPC)
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Trial Identification
Brief Title: Mitoxantrone ± Cetuximab 2nd Line Androgen Independent Prostate Cancer (AIPC)
Official Title: A Randomized Phase II Study of Mitoxantrone vs. Mitoxantrone With Cetuximab in Metastatic Androgen Independent Prostate Cancer (AIPC) Previously Treated With Docetaxel-based Chemotherapy
Study ID: NCT00661492
Conditions
Study Description
Brief Summary: 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. TTP is defined as time from the start of treatment date to the date the patient is first recorded as having disease progression, even in patients who discontinue study treatment early due to toxicity.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Hematology Oncology Associates, Phoenix, Arizona, United States
Northern AZ Hematology & Oncology Assoc, Sedona, Arizona, United States
Rocky Mountain Cancer Center-Midtown, Denver, Colorado, United States
Melbourne Internal Medicine Associates, Melbourne, Florida, United States
Florida Cancer Institute - New Hope, New Port Richey, Florida, United States
Ocala Oncology Center, Ocala, Florida, United States
Cancer Centers of Florida, P.A., Ocoee, Florida, United States
Cancer Care & Hematology Specialists of Chicagoland, Niles, Illinois, United States
Central Indiana Cancer Centers, Indianapolis, Indiana, United States
Hope Center, Terre Haute, Indiana, United States
Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota, United States
Missouri Cancer Associates, Columbia, Missouri, United States
St. Joseph Oncology, Inc., St. Joseph, Missouri, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
NH Oncology-Hematology PA, Hooksett, New Hampshire, United States
Hematology-Oncology Associates of NNJ, P, Morristown, New Jersey, United States
Albany Medical Cancer Center, Albany, New York, United States
Interlakes Oncology Hematology, PC, Rochester, New York, United States
Cancer Centers of North Carolina, Raleigh, North Carolina, United States
Greater Dayton Cancer Center, Kettering, Ohio, United States
Willamette Valley Cancer Center, Eugene, Oregon, United States
Oregon Health & Science University, Portland, Oregon, United States
Cancer Centers of the Carolinas, Greenville, South Carolina, United States
Texas Oncology, P.A. -Amarillo, Amarillo, Texas, United States
Texas Oncology, P.A., Arlington, Texas, United States
Texas Oncology - Central Austin Cancer Center, Austin, Texas, United States
Mamie McFaddin Ward Cancer Center, Beaumont, Texas, United States
Texas Cancer Center at Medical City, Dallas, Texas, United States
Texas Oncology, P.A., Dallas, Texas, United States
Methodist Charlton Cancer Ctr., Dallas, Texas, United States
Texas Oncology, P.A., Dallas, Texas, United States
Texas Cancer Center, Denton, Texas, United States
El Paso Cancer Treatment Ctr, El Paso, Texas, United States
Texas Oncology, P.A., Ft. Worth, Texas, United States
Texas Oncology, P.A, Garland, Texas, United States
Longview Cancer Center, Longview, Texas, United States
South Texas Cancer Center - McAllen, McAllen, Texas, United States
Texas Cancer Center of Mesquite, Mesquite, Texas, United States
Allison Cancer Center, Midland, Texas, United States
Texas Oncology - Odessa, Odessa, Texas, United States
Paris Regional Cancer Center, Paris, Texas, United States
Texas Cancer Center - Sherman, Sherman, Texas, United States
Texas Oncology Cancer Center-Sugar Land, Sugar Land, Texas, United States
Tyler Cancer Center, Tyler, Texas, United States
Texas Oncology, P.A., Webster, Texas, United States
Fairfax Northern VA Hem-Onc PC, Fairfax, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Onc and Hem Associates of SW VA, Inc., Salem, Virginia, United States
Highline Medical Oncology, Burien, Washington, United States
Puget Sound Cancer Center-Edmonds, Edmonds, Washington, United States
Columbia Basin Hematology and Oncology, Kennewick, Washington, United States
Puget Sound Cancer Center-Seattle, Seattle, Washington, United States
Cancer Care Northwest-South, Spokane, Washington, United States
Northwest Cancer Specialists-Vancouver, Vancouver, Washington, United States
Yakima Valley Mem Hosp/North Star Lodge, Yakima, Washington, United States
Contact Details
Name: Mark T. Fleming, MD
Affiliation: Virginia Oncology Associates/US Oncology
Role: PRINCIPAL_INVESTIGATOR
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