Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decrease… (NCT00005644) | Clinical Trial Compass
CompletedPhase 2
Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function
United StatesStarted 2001-01-02
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced cancer of the urothelium with decreased kidney function.
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 progressive regional or metastatic transitional cell carcinoma of the urothelium
* Mixed histologies containing a component of transitional cell carcinoma allowed
* Bidimensionally measurable disease
* No clinical evidence of CNS metastases
* Clinically unsuspected organ-confined prostate cancer found at time of cystoprostatectomy allowed
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 2.5 times upper limit of normal (ULN) and alkaline phosphatase normal OR
* Alkaline phosphatase no greater than 4 times ULN and SGOT normal OR
* SGOT less than 1.5 times ULN and alkaline phosphatase less than 2.5 times ULN
Renal:
* Creatinine no greater than 3.0 mg/dL
* Glomerular filtration rate no greater than 50 mL/min
Cardiovascular:
* No history of American Heart Association class III or IV heart disease
* No uncontrolled congestive heart failure
* No severe cardiac arrhythmias
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No preexisting peripheral neuropathy grade 2 or greater
* No active unresolved infection requiring parenteral antibiotics within the past 7 days
* No other malignancy within the past 5 years except curatively treated basal cell o…