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

Bladder Cancer Clinical Trial

Official title:

Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00053209
• Other study ID #: CDR0000269302
• Secondary ID: ECOG-E4802
• Status: Completed
• Phase: Phase 2
• Start date: August 10, 2004
• Est. completion date: May 2009

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2009
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Kidney Neoplasms
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Ureteral Neoplasms
• Urethral Cancer
• Urethral Neoplasms
• Urinary Bladder Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• pemetrexed disodium

Locations

Country	Name	City	State
United States	Cancer Care Institute of Carolina at Aiken Regional Medical Centers	Aiken	South Carolina
United States	McFarland Clinic, P.C.	Ames	Iowa
United States	Hematology and Oncology of Northeast Georgia	Athens	Georgia
United States	MBCCOP-Medical College of Georgia Cancer Center	Augusta	Georgia
United States	Aurora Presbyterian Hospital	Aurora	Colorado
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	MeritCare Clinic - Bemidji	Bemidji	Minnesota
United States	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania
United States	Boulder Community Hospital	Boulder	Colorado
United States	Our Lady of Mercy Medical Center Comprehensive Cancer Center	Bronx	New York
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees	Camden	New Jersey
United States	Aultman Hospital Cancer Center at Aultman Health Foundation	Canton	Ohio
United States	Cancer Center of Kansas - Chanute	Chanute	Kansas
United States	Erlanger Cancer Center	Chattanooga	Tennessee
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	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	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado
United States	Porter Adventist Hospital	Denver	Colorado
United States	Presbyterian - St. Luke's Medical Center	Denver	Colorado
United States	Rose Medical Center	Denver	Colorado
United States	St. Joseph Hospital	Denver	Colorado
United States	Cancer Center of Kansas - Dodge City	Dodge City	Kansas
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	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Union Hospital Cancer Center at Union Hospital	Elkton	Maryland
United States	Swedish Medical Center	Englewood	Colorado
United States	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	MeritCare Medical Group	Fargo	North Dakota
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology, Limited at St. Vincent Hospital	Green Bay	Wisconsin
United States	St. Mary's Hospital Medical Center	Green Bay	Wisconsin
United States	St. Vincent Hospital	Green Bay	Wisconsin
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	Green Bay Oncology, Limited - Iron Mountain	Iron Mountain	Michigan
United States	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida
United States	Joliet Oncology Hematology Associates, Limited - West	Joliet	Illinois
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Cancer Center of Kansas - Kingman	Kingman	Kansas
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Watson Clinic, LLC	Lakeland	Florida
United States	Central Pennsylvania Hematology and Medical Oncology Associates, P. C.	Lemoyne	Pennsylvania
United States	Beebe Medical Center	Lewes	Delaware
United States	Southwest Medical Center	Liberal	Kansas
United States	Meeker County Memorial Hospital	Litchfield	Minnesota
United States	Sky Ridge Medical Center	Lone Tree	Colorado
United States	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado
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	St. John's Hospital	Maplewood	Minnesota
United States	Fox Chase Virtua Health Cancer Program - Marlton	Marlton	New Jersey
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota
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	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Yale Comprehensive Cancer Center at Yale University School of Medicine	New Haven	Connecticut
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Cancer Center of Kansas - Newton	Newton	Kansas
United States	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin
United States	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Fox Chase-Temple Cancer Center	Philadelphia	Pennsylvania
United States	Saint Joseph Regional Medical Center - Plymouth Campus	Plymouth	Indiana
United States	Pratt Cancer Center of Kansas	Pratt	Kansas
United States	St. Mary-Corwin Regional Medical Center	Pueblo	Colorado
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	Cancer Center of Kansas - Salina	Salina	Kansas
United States	Saint Francis Cancer Center	Shakopee	Minnesota
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates	Sioux City	Iowa
United States	Siouxland Regional Cancer Center	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
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	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin
United States	Overlook Hospital	Summit	New Jersey
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	North Suburban Medical Center	Thornton	Colorado
United States	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Cancer Center of Kansas - Wellington	Wellington	Kansas
United States	Chester County Hospital	West Chester	Pennsylvania
United States	Reading Hospital and Medical Center	West Reading	Pennsylvania
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	St. Francis Hospital	Wilmington	Delaware
United States	Cancer Center of Kansas - Winfield	Winfield	Kansas
United States	Woodwinds Hospital	Woodbury	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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): — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response as measured by RECIST criteria		Assessed every 6 weeks
Secondary	Time to disease progression		Assessed every 6 weeks
Secondary	Overall survival		Assessed every 3 months for 2 years, then every 6 months for 3 years