Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
NCT ID: NCT00053209
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2004-08-10
2009-05-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pemetrexed Disodium and Gemcitabine
Pemetrexed disodium 500 mg/m2 followed by gemcitabine 1000 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on day 8 of a 21-day cycle for a maximum of 6 cycles
gemcitabine hydrochloride
pemetrexed disodium
Interventions
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gemcitabine hydrochloride
pemetrexed disodium
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Robert Dreicer, MD, FACP
Role: STUDY_CHAIR
The Cleveland Clinic
Locations
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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
The 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
Countries
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References
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Dreicer R, Li H, Cooney MM, Wilding G, Roth BJ; Eastern Cooperative Oncology Group. Phase 2 trial of pemetrexed disodium and gemcitabine in advanced urothelial cancer (E4802): a trial of the Eastern Cooperative Oncology Group. Cancer. 2008 Jun 15;112(12):2671-5. doi: 10.1002/cncr.23503.
Li S, Dreicer R, Roth B, et al.: Phase II trial of pemetrexed disodium and gemcitabine in advanced carcinoma of the urothelium (E4802): a trial of the Eastern Cooperative Oncology Group. [Abstract] J Clin Oncol 25 (Suppl 18): A-5079, 254s, 2007.
Other Identifiers
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ECOG-E4802
Identifier Type: -
Identifier Source: secondary_id
CDR0000269302
Identifier Type: -
Identifier Source: org_study_id
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