Bladder Cancer Clinical Trial

Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed cancer of the urothelium (renal pelvis, ureter, bladder, or urethra)

Any of the following types:

Transitional cell carcinoma (TCC)
Mixed histologies containing a component of TCC
Non-TCC of the urothelium (renal pelvis, ureter, bladder, or urethra)
Progressing regional or metastatic disease
Measurable disease
No clinical evidence of CNS metastases
No evidence of clinically significant (by physical exam or plain film) third-space fluid collections (pleural effusions or ascites)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 9 g/dL

Hepatic

AST no greater than 3 times upper limit of normal (ULN)
Bilirubin no greater than 1.5 times ULN

Renal

Creatinine clearance at least 45 mL/min

Cardiovascular

No history of severe cardiovascular disease (i.e., American Heart Association class III or IV heart disease)
No uncontrolled congestive heart failure
No ventricular dysrhythmias

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No active unresolved infection
No other prior malignancy unless curatively treated and disease free for an appropriate (disease-specific) period of time
Able and willing to receive folic acid and cyanocobalamin supplementation

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior systemic biologic response modifier therapy

Chemotherapy

No prior systemic chemotherapy for metastatic disease
More than 1 year since prior neoadjuvant or adjuvant chemotherapy

Endocrine therapy

Not specified

Radiotherapy

At least 4 weeks since prior radiotherapy and recovered
No prior pelvic radiotherapy
No concurrent radiotherapy

Surgery

At least 4 weeks since prior major surgery and recovered

Other

More than 7 days since prior parenteral antibiotics
No salicylates for 2 days before, during, and for 2 days after administration of pemetrexed disodium
No nonsteroidal anti-inflammatory drugs for at least 5 days before, during, and for 2 days after administration of pemetrexed disodium

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

46

Study ID:

NCT00053209

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 104 Locations for this study

See Locations Near You

Aurora Presbyterian Hospital
Aurora Colorado, 80012, United States
Boulder Community Hospital
Boulder Colorado, 80301, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs Colorado, 80933, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver Colorado, 80218, United States
St. Joseph Hospital
Denver Colorado, 80218, United States
Rose Medical Center
Denver Colorado, 80220, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver Colorado, 80224, United States
Swedish Medical Center
Englewood Colorado, 80110, United States
Sky Ridge Medical Center
Lone Tree Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont Colorado, 80502, United States
St. Mary-Corwin Regional Medical Center
Pueblo Colorado, 81004, United States
North Suburban Medical Center
Thornton Colorado, 80229, United States
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven Connecticut, 06520, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19718, United States
St. Francis Hospital
Wilmington Delaware, 19805, United States
Baptist Cancer Institute - Jacksonville
Jacksonville Florida, 32207, United States
Watson Clinic, LLC
Lakeland Florida, 33805, United States
Hematology and Oncology of Northeast Georgia
Athens Georgia, 30607, United States
MBCCOP-Medical College of Georgia Cancer Center
Augusta Georgia, 30912, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
Hinsdale Hematology Oncology Associates
Hinsdale Illinois, 60521, United States
Joliet Oncology Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Regional Cancer Center at Memorial Medical Center
Springfield Illinois, 62781, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
Saint Joseph Regional Medical Center - Plymouth Campus
Plymouth Indiana, 46544, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
McFarland Clinic, P.C.
Ames Iowa, 50010, United States
Siouxland Regional Cancer Center
Sioux City Iowa, 51101, United States
Siouxland Hematology-Oncology Associates
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Cancer Center of Kansas - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, P.A. - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, P.A. - Parsons
Parsons Kansas, 67357, United States
Pratt Cancer Center of Kansas
Pratt Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health
Wichita Kansas, 67203, United States
Cancer Center of Kansas, P.A.
Wichita Kansas, 67208, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield Kansas, 67156, United States
Union Hospital Cancer Center at Union Hospital
Elkton Maryland, 21921, United States
Green Bay Oncology, Limited - Escanaba
Escanaba Michigan, 49431, United States
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain Michigan, 49801, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
MeritCare Clinic - Bemidji
Bemidji Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Miller-Dwan Medical Center
Duluth Minnesota, 55805, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth Minnesota, 55805, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield Minnesota, 55355, United States
St. John's Hospital
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis Minnesota, 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale Minnesota, 55422, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Health Services
Saint Louis Park Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul Minnesota, 55101, United States
St. Joseph's Hospital
Saint Paul Minnesota, 55102, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Saint Francis Cancer Center
Shakopee Minnesota, 55379, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Woodwinds Hospital
Woodbury Minnesota, 55125, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Camden New Jersey, 08103, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07018, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Cancer Institute of New Jersey at Hamilton
Hamilton New Jersey, 08690, United States
Fox Chase Virtua Health Cancer Program - Marlton
Marlton New Jersey, 08053, United States
Mountainside Hospital Cancer Center
Montclair New Jersey, 07042, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown New Jersey, 07962, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick New Jersey, 08903, United States
Overlook Hospital
Summit New Jersey, 07902, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx New York, 10466, United States
CCOP - MeritCare Hospital
Fargo North Dakota, 58122, United States
MeritCare Medical Group
Fargo North Dakota, 58122, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton Ohio, 44710, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland Ohio, 44106, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa Oklahoma, 74136, United States
St. Luke's Hospital Cancer Center
Bethlehem Pennsylvania, 18015, United States
Central Pennsylvania Hematology and Medical Oncology Associates, P. C.
Lemoyne Pennsylvania, 17043, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Fox Chase-Temple Cancer Center
Philadelphia Pennsylvania, 19111, United States
Chester County Hospital
West Chester Pennsylvania, 19380, United States
Reading Hospital and Medical Center
West Reading Pennsylvania, 19612, United States
Cancer Care Institute of Carolina at Aiken Regional Medical Centers
Aiken South Carolina, 29802, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota, 57104, United States
Avera McKennan Hospital and University Health Center
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center
Sioux Falls South Dakota, 57105, United States
Erlanger Cancer Center
Chattanooga Tennessee, 37403, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay Wisconsin, 54301, United States
St. Vincent Hospital
Green Bay Wisconsin, 54301, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay Wisconsin, 54303, United States
St. Mary's Hospital Medical Center
Green Bay Wisconsin, 54303, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Cancer Care Center at Holy Family Memorial Medical Center
Manitowoc Wisconsin, 54221, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls Wisconsin, 54154, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay Wisconsin, 54235, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

46

Study ID:

NCT00053209

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

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