Paclitaxel in Treating Patients With Early-Stage Bladder Cancer
- Conditions
- Bladder Cancer
- Registration Number
- NCT00002917
- Lead Sponsor
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel in treating patients with early-stage bladder cancer.
- Detailed Description
OBJECTIVES: I. Evaluate toxicity and safety of intravesical paclitaxel in patients with superficial bladder cancer. II. Evaluate the efficacy of paclitaxel against transitional cell carcinoma in situ (CIS) and/or unresectable papillary superficial bladder cancer. III. Evaluate a dose-response effect and choose an appropriate dose for further clinical study.
OUTLINE: Cohorts of patients receive intravesical paclitaxel in escalating doses, administered twice weekly for 6 weeks, then once every 2 weeks for another 6 weeks, for a maximum of 2 courses at a dose level. Patients must complete 8 of the first 15 instillations and a 3 month cystoscopic exam with biopsy and cytology to be deemed evaluable. Participants are followed by quarterly cytoscopy and cytology for an additional 21 month period. Biopsies are performed at 3 and/or 6 months, and thereafter if clinically applicable.
PROJECTED ACCRUAL: 19 evaluable patients will be enrolled.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States