Spots Global Cancer Trial Database for Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
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Trial Identification
Brief Title: Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
Official Title: Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer
Study ID: NCT00053209
Study Description
Brief Summary: RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with gemcitabine in treating patients who have advanced cancer of the urothelium.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aurora Presbyterian Hospital, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States
St. Joseph Hospital, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States
St. Mary-Corwin Regional Medical Center, Pueblo, Colorado, United States
North Suburban Medical Center, Thornton, Colorado, United States
Yale Comprehensive Cancer Center at Yale University School of Medicine, New Haven, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
St. Francis Hospital, Wilmington, Delaware, United States
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States
Watson Clinic, LLC, Lakeland, Florida, United States
Hematology and Oncology of Northeast Georgia, Athens, Georgia, United States
MBCCOP-Medical College of Georgia Cancer Center, Augusta, Georgia, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, United States
Joliet Oncology Hematology Associates, Limited - West, Joliet, Illinois, United States
Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
Saint Joseph Regional Medical Center - Plymouth Campus, Plymouth, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
McFarland Clinic, P.C., Ames, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
Siouxland Hematology-Oncology Associates, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Cancer Center of Kansas - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Kingman, Kingman, Kansas, United States
Southwest Medical Center, Liberal, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons, Parsons, Kansas, United States
Pratt Cancer Center of Kansas, Pratt, Kansas, United States
Cancer Center of Kansas - Salina, Salina, Kansas, United States
Cancer Center of Kansas - Wellington, Wellington, Kansas, United States
Associates in Womens Health, Wichita, Kansas, United States
Cancer Center of Kansas, P.A., Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
Union Hospital Cancer Center at Union Hospital, Elkton, Maryland, United States
Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States
Green Bay Oncology, Limited - Iron Mountain, Iron Mountain, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
MeritCare Clinic - Bemidji, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
CCOP - Duluth, Duluth, Minnesota, United States
Miller-Dwan Medical Center, Duluth, Minnesota, United States
St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
Meeker County Memorial Hospital, Litchfield, Minnesota, United States
St. John's Hospital, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center, Robbinsdale, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Health Services, Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center, Saint Paul, Minnesota, United States
St. Joseph's Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Cancer Center, Shakopee, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Woodwinds Hospital, Woodbury, Minnesota, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees, Camden, New Jersey, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
Cancer Institute of New Jersey at Hamilton, Hamilton, New Jersey, United States
Fox Chase Virtua Health Cancer Program - Marlton, Marlton, New Jersey, United States
Mountainside Hospital Cancer Center, Montclair, New Jersey, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital, Morristown, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Overlook Hospital, Summit, New Jersey, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center, Bronx, New York, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
MeritCare Medical Group, Fargo, North Dakota, United States
Aultman Hospital Cancer Center at Aultman Health Foundation, Canton, Ohio, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
St. Luke's Hospital Cancer Center, Bethlehem, Pennsylvania, United States
Central Pennsylvania Hematology and Medical Oncology Associates, P. C., Lemoyne, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Fox Chase-Temple Cancer Center, Philadelphia, Pennsylvania, United States
Chester County Hospital, West Chester, Pennsylvania, United States
Reading Hospital and Medical Center, West Reading, Pennsylvania, United States
Cancer Care Institute of Carolina at Aiken Regional Medical Centers, Aiken, South Carolina, United States
Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, United States
Avera McKennan Hospital and University Health Center, Sioux Falls, South Dakota, United States
Medical X-Ray Center, Sioux Falls, South Dakota, United States
Erlanger Cancer Center, Chattanooga, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Green Bay Oncology, Limited at St. Vincent Hospital, Green Bay, Wisconsin, United States
St. Vincent Hospital, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center, Green Bay, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Cancer Care Center at Holy Family Memorial Medical Center, Manitowoc, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Contact Details
Name: Robert Dreicer, MD, FACP
Affiliation: The Cleveland Clinic
Role: STUDY_CHAIR
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