Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer
OBJECTIVES:
Primary
- Determine the response rate in patients with previously untreated advanced cancer of
the urothelium treated with pemetrexed disodium and gemcitabine.
- Determine the toxicity of this regimen in these patients.
Secondary
- Determine the overall survival and time to progression in patients treated with this
regimen.
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes on day 1 and gemcitabine IV over 30
minutes on days 1 and 8. Patients also receive cyanocobalamin intramuscularly once every 9
weeks and folic acid orally once daily beginning on day -6 and continuing until 3 weeks
after the completion of study therapy. Treatment repeats every 3 weeks for up to 6 courses
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.
PROJECTED ACCRUAL: A total of 24-46 patients will be accrued for this study within 15 -18
months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response as measured by RECIST criteria
Assessed every 6 weeks
No
Robert Dreicer, MD, FACP
Study Chair
The Cleveland Clinic
United States: Federal Government
CDR0000269302
NCT00053209
April 2004
May 2009
Name | Location |
---|---|
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
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 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
CCOP - Duluth | 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 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
St. Luke's Hospital Cancer Center | Bethlehem, Pennsylvania 18015 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
Fox Chase-Temple Cancer Center | Philadelphia, Pennsylvania 19111-2442 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
Chester County Hospital | West Chester, Pennsylvania 19380 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Siouxland Hematology-Oncology Associates | Sioux City, Iowa 51101 |
Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas, P.A. - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Kingman | Kingman, Kansas 67068 |
Southwest Medical Center | Liberal, Kansas 67901 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, P.A. - Parsons | Parsons, Kansas 67357 |
Pratt Cancer Center of Kansas | Pratt, Kansas 67124 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, P.A. | Wichita, Kansas 67208 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas, P.A. - Wichita | Wichita, Kansas 67214 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Fox Chase Virtua Health Cancer Program - Marlton | Marlton, New Jersey 08053 |
Avera McKennan Hospital and University Health Center | Sioux Falls, South Dakota 57105 |
Medical X-Ray Center | Sioux Falls, South Dakota 57105 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
MBCCOP-Medical College of Georgia Cancer Center | Augusta, Georgia 30912-4000 |
Yale Comprehensive Cancer Center at Yale University School of Medicine | New Haven, Connecticut 06520-8064 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | Camden, New Jersey 08103 |
St. Mary-Corwin Regional Medical Center | Pueblo, Colorado 81004 |
Beebe Medical Center | Lewes, Delaware 19958 |
St. Francis Hospital | Wilmington, Delaware 19805 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Union Hospital Cancer Center at Union Hospital | Elkton MD, Maryland 21921 |
Green Bay Oncology, Limited - Iron Mountain | Iron Mountain, Michigan 49801 |
MeritCare Clinic - Bemidji | Bemidji, Minnesota 56601 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
Mountainside Hospital Cancer Center | Montclair, New Jersey 07042 |
MeritCare Medical Group | Fargo, North Dakota 58122 |
Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Joliet Oncology Hematology Associates, Limited - West | Joliet, Illinois 60435 |
McFarland Clinic, P.C. | Ames, Iowa 50010 |
Miller-Dwan Medical Center | Duluth, Minnesota 55805 |
St. John's Hospital | Maplewood, Minnesota 55109 |
Saint Joseph Regional Medical Center - Plymouth Campus | Plymouth, Indiana 46544 |
Saint Francis Cancer Center | Shakopee, Minnesota 55379 |
St. Joseph's Hospital | St Paul, Minnesota 55102 |
Woodwinds Hospital | Woodbury, Minnesota 55125 |
St. Mary's Hospital Medical Center | Green Bay, Wisconsin 54303 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Cancer Care Institute of Carolina at Aiken Regional Medical Centers | Aiken, South Carolina 29801 |
Watson Clinic, LLC | Lakeland, Florida 33804-5000 |
Hematology and Oncology of Northeast Georgia | Athens, Georgia 30607 |
Erlanger Cancer Center | Chattanooga, Tennessee 37403 |
Central Pennsylvania Hematology and Medical Oncology Associates, P. C. | Lemoyne, Pennsylvania 17043 |
Cancer Care Center at Holy Family Memorial Medical Center | Manitowoc, Wisconsin 54221 |