Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Doxorubicin; Gemcitabine; Liposomal doxorubicin; Paclitaxel

Criteria

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 cancer and in situ carcinoma of the cervix curatively treated

• Not pregnant

• Effective barrier contraception required for all fertile patients during and for 6 months after therapy (encouraged to continue for 2 years or longer)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior systemic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to the bladder

• At least 4 weeks since any other prior radiotherapy

Surgery:

• See Disease Characteristics