Phase II Study of a Weekly Schedule of BMS-247550 for Patients With Hormone Refractory Prostate Cancer
OBJECTIVES:
Primary
- To determine the effect on percent with a 50% decrease in prostate specific antigen
(PSA) response in patients with metastatic prostate cancer who have progressed on
androgen ablation therapy and are classified into 1 of 3 separate categories:
- Never received prior chemotherapy/cytotoxic therapy
- Received prior taxane-based regimen
- Received 2 prior cytotoxic chemotherapy regimens (including, but not limited to,
prior taxane and anthracyclines)
Secondary
- Determine measurable disease response in patients with measurable disease treated with
this drug and overall response rate.
- Determine the toxic effects of this drug in these patients.
- Determine the duration of PSA and measurable disease response in patients treated with
this drug.
- Determine the expression of p53, multidrug resistance protein, and Bcl-2 by
immunohistochemistry in the primary tumors of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens).
Patients receive ixabepilone intravenously (IV) over 1 hour on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
ACTUAL ACCRUAL: A total of 124 patients (39 for the no prior chemotherapy stratum; 49 for
the prior taxane stratum; 36 for the 2 prior cytotoxic chemotherapy regimens) were accrued
for this study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of Patients With PSA Response
PSA response is defined as a decline from baseline value by >=50%, or normalization of PSA (PSA < 0.2 ng/lm), confirmed by a second measurement >= 4 weeks later. The proportion of patients with PSA response was reported separately for 3 strata. Additional patients accrued to this study were not included in this analysis.
Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry
No
Glenn Liu, MD
Study Chair
University of Wisconsin, Madison
United States: Food and Drug Administration
NCI-2009-00548
NCT00087139
September 2004
January 2014
Name | Location |
---|---|
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
CCOP - Colorado Cancer Research Program | Denver, Colorado 80224-2522 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Duluth Clinic Cancer Center - Duluth | Duluth, Minnesota 55805-1983 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
HealthEast Cancer Care at St. Joseph's Hospital | St Paul, Minnesota 55102 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
HealthEast Cancer Care at Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Mercy Cancer Center at Mercy Medical Center | Canton, Ohio 44708 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Columbus | Columbus, Ohio 43206 |
Hinsdale, Illinois 60521 | |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Southwest Medical Center | Liberal, Kansas 67901 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
South Bend Clinic | South Bend, Indiana 46617 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland, Florida 33805 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Bettendorf, Iowa 52722 | |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Terrebonne General Medical Center | Houma, Louisiana 70360 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Mercy Medical Center | Springfield, Ohio 45504 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Ochsner Health Center - Bluebonnet | Baton Rouge, Louisiana 70809 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire, Wisconsin 54701 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center | Green Bay, Wisconsin 54311 |
Saint Joseph's Hospital | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
Saint Michael's Hospital Cancer Center | Stevens Point, Wisconsin 54481 |
Marshfield Clinic - Wausau Center | Wausau, Wisconsin 54401 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Sherman Hospital | Elgin, Illinois 60120-2198 |
Central Pennsylvania Hematology and Medical Oncology Associates, PC | Lemoyne, Pennsylvania 17043 |
University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau, Wisconsin 54401 |
Alexian Brothers Radiation Oncology | Elk Grove Village, Illinois 60007 |
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline, Illinois 61265 |
Hattiesburg Clinic, PA at Forrest General | Hattiesburg, Mississippi 39401 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
CCOP - Main Line Health | Wynnewood, Pennsylvania 19096 |
Hematology & Oncology Clinic | Hattiesburg, Mississippi 39402 |
Langlade Memorial Hospital | Antigo, Wisconsin 54409 |
UW Health Urology | Madison, Wisconsin 53715 |