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

NCT00053209 | Completed Phase 2

• 2 other identifiers: CDR0000269302ECOG-E4802
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 121

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.

Conditions

Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer

Keywords

metastatic transitional cell cancer of the renal pelvis and ureter; recurrent transitional cell cancer of the renal pelvis and ureter; regional transitional cell cancer of the renal pelvis and ureter; transitional cell carcinoma of the bladder; recurrent bladder cancer; stage III bladder cancer; stage IV bladder cancer; anterior urethral cancer; posterior urethral cancer; recurrent urethral cancer; urethral cancer associated with invasive bladder cancer

Outcome Measures

Primary Outcomes (1)

• Response as measured by RECIST criteria

  Assessed every 6 weeks

Secondary Outcomes (2)

• Time to disease progression

  Assessed every 6 weeks

• Overall survival

  Assessed every 3 months for 2 years, then every 6 months for 3 years

Study Arms (1)

Pemetrexed Disodium and Gemcitabine

EXPERIMENTAL

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

Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium

Interventions

gemcitabine hydrochloride DRUG

Pemetrexed Disodium and Gemcitabine

pemetrexed disodium DRUG

Pemetrexed Disodium and Gemcitabine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (121)

Aurora Presbyterian Hospital

Aurora, Colorado, 80012, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301, United States

Location

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, 80933, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Presbyterian - St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

St. Joseph Hospital

Denver, Colorado, 80218, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224-2522, United States

Location

Swedish Medical Center

Englewood, Colorado, 80110, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, 80502, United States

Location

St. Mary-Corwin Regional Medical Center

Pueblo, Colorado, 81004, United States

Location

North Suburban Medical Center

Thornton, Colorado, 80229, United States

Location

Yale Comprehensive Cancer Center at Yale University School of Medicine

New Haven, Connecticut, 06520-8032, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

St. Francis Hospital

Wilmington, Delaware, 19805, United States

Location

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

Watson Clinic, LLC

Lakeland, Florida, 33805, United States

Location

Hematology and Oncology of Northeast Georgia

Athens, Georgia, 30607, United States

Location

MBCCOP-Medical College of Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

Joliet Oncology Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

Saint Joseph Regional Medical Center - Plymouth Campus

Plymouth, Indiana, 46544, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

McFarland Clinic, P.C.

Ames, Iowa, 50010, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101-1733, United States

Location

Siouxland Hematology-Oncology Associates

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, P.A. - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, P.A. - Parsons

Parsons, Kansas, 67357, United States

Location

Pratt Cancer Center of Kansas

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67042, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, P.A.

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, P.A. - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

Union Hospital Cancer Center at Union Hospital

Elkton, Maryland, 21921, United States

Location

Green Bay Oncology, Limited - Escanaba

Escanaba, Michigan, 49431, United States

Location

Green Bay Oncology, Limited - Iron Mountain

Iron Mountain, Michigan, 49801, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49001, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

MeritCare Clinic - Bemidji

Bemidji, Minnesota, 56601, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Miller-Dwan Medical Center

Duluth, Minnesota, 55805, United States

Location

St. Mary's - Duluth Clinic Cancer Center

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

Meeker County Memorial Hospital

Litchfield, Minnesota, 55355, United States

Location

St. John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

Robbinsdale, Minnesota, 55422, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Health Services

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Saint Francis Cancer Center

Shakopee, Minnesota, 55379, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Woodwinds Hospital

Woodbury, Minnesota, 55125, United States

Location

Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

Camden, New Jersey, 08103, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07018-1095, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Fox Chase Virtua Health Cancer Program - Marlton

Marlton, New Jersey, 08053, United States

Location

Mountainside Hospital Cancer Center

Montclair, New Jersey, 07042, United States

Location

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Overlook Hospital

Summit, New Jersey, 07902, United States

Location

Our Lady of Mercy Medical Center Comprehensive Cancer Center

The Bronx, New York, 10466, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

MeritCare Medical Group

Fargo, North Dakota, 58122, United States

Location

Aultman Hospital Cancer Center at Aultman Health Foundation

Canton, Ohio, 44710, United States

Location

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MetroHealth's Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

St. Luke's Hospital Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Central Pennsylvania Hematology and Medical Oncology Associates, P. C.

Lemoyne, Pennsylvania, 17043, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase-Temple Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Chester County Hospital

West Chester, Pennsylvania, 19380, United States

Location

Reading Hospital and Medical Center

West Reading, Pennsylvania, 19612, United States

Location

Cancer Care Institute of Carolina at Aiken Regional Medical Centers

Aiken, South Carolina, 29802, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57104, United States

Location

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center

Sioux Falls, South Dakota, 57105, United States

Location

Erlanger Cancer Center

Chattanooga, Tennessee, 37403, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Green Bay Oncology, Limited at St. Vincent Hospital

Green Bay, Wisconsin, 54301-3526, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

St. Mary's Hospital Medical Center

Green Bay, Wisconsin, 54303, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Cancer Care Center at Holy Family Memorial Medical Center

Manitowoc, Wisconsin, 54221, United States

Location

Green Bay Oncology, Limited - Oconto Falls

Oconto Falls, Wisconsin, 54154, United States

Location

Green Bay Oncology, Limited - Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235, United States

Location

Related Publications (2)

• 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.

  PMID: 18459175 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urethral Neoplasms

Interventions

Gemcitabine; Pemetrexed

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urethral Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Robert Dreicer, MD, FACP

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2003
• First Posted: January 28, 2003
• Study Start: August 10, 2004
• Primary Completion: September 1, 2007
• Study Completion: May 1, 2009
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (121)