A PHASE I/II INSTITUTIONAL STUDY OF INTRAVESICAL TAXOL (PACLITAXEL) INSTILLATION FOR THE TREATMENT OF SUPERFICIAL BLADDER CANCER
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.
Primary Purpose: Treatment
Donald L. Lamm, MD
United States: Federal Government
|West Virginia University Hospitals||Morgantown, West Virginia 26506-9300|