Overview

Combination Chemotherapy Following Surgery in Treating Patients With Advanced Bladder Cancer

Status:
Completed
Trial end date:
2003-01-01
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 II trial to study the effectiveness of combination chemotherapy following surgery in treating patients with advanced bladder cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Cisplatin
Doxorubicin
Gemcitabine
Liposomal doxorubicin
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Pathologically proven complete resection of locally advanced
transitional cell carcinoma of the urothelium with negative margins Disease extends beyond
the bladder, the ureter, or into the regional lymph nodes Stages eligible for patients with
bladder cancer: Tany, N+, M0 T3b, N0, M0 T4a, N0, M0 Stages eligible for patients with
urothelial cancer of the renal pelvis or ureter: Tany, N+, M0 T3, N0, M0 T4, N0, M0 Local
control of primary urothelial tumor obtained by: Cystoprostatectomy plus pelvic lymph node
dissection for bladder cancer in males Cystectomy/TAH/BSO and pelvic lymph node dissection
for bladder cancer in females Nephroureterectomy for disease involving the renal pelvis or
ureter

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% ECOG 0-1
Life expectancy: Not specified Hematopoietic: Platelet count at least 150,000/mm3
Granulocyte count at least 1500/mm3 Hepatic: Bilirubin less than 1.5 times normal SGOT and
alkaline phosphatase less than 2 times normal Renal: Creatinine less than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/ min Cardiovascular: LVEF at least 50% No New York
Heart Association class II or IV heart disease No serious cardiac arrhythmias, including
first, second, or third degree heart block Other: No concurrent second malignancy except
nonmelanomatous skin cancer or curatively treated in situ carcinoma of the cervix No
uncontrolled infection Fertile patients must use barrier method contraception before,
during, and for 6 months after therapy and are encouraged to continue barrier method
contraception for 2 years or longer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior irradiation of the
bladder Surgery: See Disease Characteristics Definitive surgery performed within 10 weeks
of study treatment start