Sequential Gemcitabine, Doxorubicin, Then Paclitaxel Plus Cisplatin Adjuvant Chemotherapy After Complete Resection of Locally Advanced Transitional Cell Carcinoma of the Urothelium
18 Years
N/A
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
Trial Information
Sequential Gemcitabine, Doxorubicin, Then Paclitaxel Plus Cisplatin Adjuvant Chemotherapy After Complete Resection of Locally Advanced Transitional Cell Carcinoma of the Urothelium
OBJECTIVES: I. Determine the safety and toxicity of sequential dose intensive adjuvant
systemic therapy consisting of gemcitabine, then doxorubin, followed by paclitaxel and
cisplatin with filgrastim (granulocyte colony stimulating factor; G-CSF) for patients with
completely resected, locally advanced transitional cell carcinoma of the urothelium. II.
Assess the disease free and overall survival of these patients.
OUTLINE: Patients receive gemcitabine IV on weeks 1, 2, 3, 5, 6, and 7 for a total of 6
doses. A 1 week rest period occurs after the third dose of gemcitabine. At least 14 days
after the last dose of gemcitabine, during the ninth week, patients receive doxorubicin at 2
week intervals (weeks 9, 11, 13, and 15) for a total of 4 doses. Filgrastim (granulocyte
colony stimulating factor; G-CSF) is administered subcutaneously on days 3-10 of each cycle
of doxorubicin. At least 14 days after the last dose of doxorubicin, during week 17,
patients receive the combination of paclitaxel IV (3 hour infusion) and cisplatin, at 2 week
intervals (weeks 17, 19, 21, and 23) for a total of 4 doses. G-CSF is again administered on
days 3-10 of each of these cycles. Patients are followed every 3 months for the first 2
years, every 6 months for the next 3 years, then annually until death.
PROJECTED ACCRUAL: This study will accrue 25-30 patients in 1.5-2 years.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Dean F. Bajorin, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
97-106
NCT ID:
NCT00003133
Start Date:
September 1997
Completion Date:
January 2003
Related Keywords:
- Bladder Cancer
- Transitional Cell Cancer of the Renal Pelvis and Ureter
- stage III bladder cancer
- stage IV bladder cancer
- transitional cell carcinoma of the bladder
- metastatic transitional cell cancer of the renal pelvis and ureter
- regional transitional cell cancer of the renal pelvis and ureter
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Kidney Neoplasms
- Ureteral Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
