Paclitaxel in Treating Patients With Early-Stage Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT00002917|
Recruitment Status : Completed
First Posted : May 26, 2004
Last Update Posted : May 15, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: paclitaxel||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A PHASE I/II INSTITUTIONAL STUDY OF INTRAVESICAL TAXOL (PACLITAXEL) INSTILLATION FOR THE TREATMENT OF SUPERFICIAL BLADDER CANCER|
|Study Start Date :||November 1996|
|Actual Study Completion Date :||May 2004|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002917
|United States, West Virginia|
|West Virginia University Hospitals|
|Morgantown, West Virginia, United States, 26506-9162|
|Study Chair:||Donald L. Lamm, MD||Mayo Clinic|