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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 104 Locations for this study
Aurora Colorado, 80012, United States
Boulder Colorado, 80301, United States
Colorado Springs Colorado, 80933, United States
Denver Colorado, 80210, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80220, United States
Denver Colorado, 80224, United States
Englewood Colorado, 80110, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80502, United States
Pueblo Colorado, 81004, United States
Thornton Colorado, 80229, United States
New Haven Connecticut, 06520, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19718, United States
Wilmington Delaware, 19805, United States
Jacksonville Florida, 32207, United States
Lakeland Florida, 33805, United States
Athens Georgia, 30607, United States
Augusta Georgia, 30912, United States
Aurora Illinois, 60507, United States
Hinsdale Illinois, 60521, United States
Joliet Illinois, 60435, United States
Springfield Illinois, 62781, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Elkhart Indiana, 46515, United States
La Porte Indiana, 46350, United States
Michigan City Indiana, 46360, United States
Plymouth Indiana, 46544, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
Ames Iowa, 50010, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67203, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Elkton Maryland, 21921, United States
Escanaba Michigan, 49431, United States
Iron Mountain Michigan, 49801, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Bemidji Minnesota, 56601, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Litchfield Minnesota, 55355, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Waconia Minnesota, 55387, United States
Woodbury Minnesota, 55125, United States
Camden New Jersey, 08103, United States
East Orange New Jersey, 07018, United States
Hackensack New Jersey, 07601, United States
Hamilton New Jersey, 08690, United States
Marlton New Jersey, 08053, United States
Montclair New Jersey, 07042, United States
Morristown New Jersey, 07962, United States
New Brunswick New Jersey, 08903, United States
Summit New Jersey, 07902, United States
Bronx New York, 10466, United States
Fargo North Dakota, 58122, United States
Fargo North Dakota, 58122, United States
Canton Ohio, 44710, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Cleveland Ohio, 44195, United States
Tulsa Oklahoma, 74136, United States
Bethlehem Pennsylvania, 18015, United States
Lemoyne Pennsylvania, 17043, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19111, United States
West Chester Pennsylvania, 19380, United States
West Reading Pennsylvania, 19612, United States
Aiken South Carolina, 29802, United States
Sioux Falls South Dakota, 57104, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57105, United States
Chattanooga Tennessee, 37403, United States
Nashville Tennessee, 37232, United States
Temple Texas, 76508, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
La Crosse Wisconsin, 54601, United States
Madison Wisconsin, 53792, United States
Manitowoc Wisconsin, 54221, United States
Oconto Falls Wisconsin, 54154, United States
Sturgeon Bay Wisconsin, 54235, United States
How clear is this clinincal trial information?