A Phase II Study of Continuous 5-Fluorouracil (5-FU) in Recurrent Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urinary Tract
N/A
N/A
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
Trial Information
A Phase II Study of Continuous 5-Fluorouracil (5-FU) in Recurrent Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urinary Tract
OBJECTIVES: I. Determine the response rate and toxic effects of continuous fluorouracil in
patients with recurrent locally advanced or metastatic transitional cell urinary tract
carcinoma. II. Determine the feasibility of this treatment in this patient population.
OUTLINE: Patients receive continuous intravenous fluorouracil by a Baxter Infusor for 24
weeks. Patients are evaluated for complete and partial response at 8, 16, and 24 weeks after
the start of intravenous fluorouracil. Patients experiencing disease progression or
unacceptable toxic effects are removed from the study. Patients are followed monthly for 6
months post treatment.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven recurrent locally advanced or metastatic
transitional cell urinary tract carcinoma that has been previously untreated with systemic
chemotherapy Pelvic relapse after radiotherapy or surgery No relapse solely within a
previously irradiated field Nodal or metastatic disease Lesions within the abdomen or
pelvis must be assessed using CT scanning At least one site of disease must be previously
unirradiated and assessable for response Bone metastases cannot be used as an indicator
lesion Measurable disease
PATIENT CHARACTERISTICS: Age: Not specified Performance Status: Not specified Life
Expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Not specified Renal: Glomerular filtration rate at least 50 mL/min
Creatinine clearance at least 25 mL/min
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic
chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
Surgery: See Disease Characteristics
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Peter G. Harper, MD
Investigator Role:
Study Chair
Investigator Affiliation:
St. Thomas' Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000065985
NCT ID:
NCT00003175
Start Date:
December 1997
Completion Date:
Related Keywords:
- Bladder Cancer
- Transitional Cell Cancer of the Renal Pelvis and Ureter
- Urethral Cancer
- recurrent bladder cancer
- transitional cell carcinoma of the bladder
- recurrent urethral cancer
- recurrent transitional cell cancer of the renal pelvis and ureter
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Urethral Neoplasms
- Kidney Neoplasms
- Ureteral Neoplasms
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