Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer (NCT00003342) | Clinical Trial Compass
CompletedPhase 1
Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer
United States30 participantsStarted 1997-12
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 tumor cells.
PURPOSE: This phase I trial is studying the side effects of giving gemcitabine, doxorubicin, and paclitaxel together with carboplatin in treating patients with advanced bladder or kidney cancer and impaired kidney function.
Who can participate
Age range18 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 advanced transitional cell urothelial cancer
* Clinical Stage IV: T any, N1-3, M0; T any, N any, M1; or cT4, Nx, M0 (bladder tumors)
* Pathological Stage III or IV bladder cancer: T any, N1-3, M0; T3b, N0, M0; T4, N0, M0; and T4, Nx, M0
* Pathological Stage III or IV urothelial cancer of the renal pelvis or ureter: T any, N1-3, M0; T3, N0, M0; T4, N0, M0; and surgery has been performed within 10 weeks of initiation of therapy
* Impaired renal function (See Renal function tests)
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100% OR
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 150,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 times normal
* Alkaline phosphatase less than 2 times normal
* SGOT less than 2 times normal
Renal:
* Creatinine greater than 1.5 mg/dL but no greater than 2.5 mg/dL OR
* Creatinine clearance 30-59 mL/min
Cardiovascular:
* Normal cardiac function by history, physical examination, and chest radiograph OR
* If prior cardiac disease, left ventricular ejection fraction must be at least 50% by radionuclide ventriculogram or echocardiogram
* No serious cardiac arrhythmias; including first, second, and third degree heart block
* No New York Heart Association class III or IV heart disease
Other:
* No uncontrolled infection
* No other active cancer, except nonmelanomatous skin c…