Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Bladder Cancer

• Status: Completed
• Trial end date: 2004-08-01
• 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: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients with metastatic or locally advanced bladder cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed transitional cell carcinoma of the urothelium

• Measurable disease, defined as unresectable or metastatic urothelial tract tumors OR

• Evaluable disease, defined as T3b or T4a bladder tumors

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count greater than 1,500/mm^3

• Platelet count greater than 150,000/mm^3

Hepatic:

• Bilirubin less than 1.5 times normal

• SGOT less than 2 times normal

Renal:

• Creatinine less than 1.5 mg/dL OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• No New York Heart Association class III or IV heart disease

• No serious cardiac arrhythmias, including first, second, or third degree heart block

• LVEF at least 50%

Other:

• No uncontrolled infection

• No other active malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix

• Fertile patients must use effective barrier contraception before, during, and for 6 months after study and are encouraged to continue for 2 years or longer after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior systemic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 3 weeks since prior radiotherapy

Surgery:

• See Disease Characteristics