Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium (NCT00053209) | Clinical Trial Compass
CompletedPhase 2
Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
United States46 participantsStarted 2004-08-10
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 CONCURRE…