A Phase II Study of Continuous 5-Fluorouracil (5-FU) in Recurrent Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urinary Tract
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Medical Research Council
- Enrollment
- 45
- Locations
- 62
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of fluorouracil given as a continuous infusion in treating patients with recurrent or metastatic bladder cancer.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided