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A PHASE I/II INSTITUTIONAL STUDY OF INTRAVESICAL TAXOL (PACLITAXEL) INSTILLATION FOR THE TREATMENT OF SUPERFICIAL BLADDER CANCER


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

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Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven CIS and/or unresectable/residual
superficial bladder tumor (pTa G1-G3 to pT1 G1-G3) -confirmed by biopsy, bladder mapping,
or positive cytology Cystoscopic examination and bladder mapping must be performed within
6 weeks of study

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky of 60 to 100% Life
Expectancy: Not specified Hematopoietic: Hemoglobin greater than 11 g/dL WBC greater than
4500/mm3 Neutrophils greater than 1500/mm3 Platelet count greater than 100,000/mm3
Hepatic: Bilirubin, AST, and ALT no greater than 2.5 x normal Renal: Creatinine no greater
than 2.5 x normal Cardiovascular: No concurrent cardiovascular disease Other: No active
infection requiring concurrent therapy Not pregnant or nursing No upper renal tract
disease No concurrent malignancy except for basal or squamous cell skin cancer or
noninvasive cancer of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No intravesical BCG within 3 months prior to
study entry Prior BCG therapy is required for CIS patients (if not contraindicated)
Chemotherapy: No prior intravesical chemotherapy within 4 weeks prior to study No prior
systemic anticancer therapy within 4 months prior to study No prior paclitaxel therapy
Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy within 4 months prior
to study Surgery: Not specified Other: No hypersensitivity reactions to products
containing cremophor

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Donald L. Lamm, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

WVU-13707-OSP-97-092

NCT ID:

NCT00002917

Start Date:

November 1996

Completion Date:

May 2004

Related Keywords:

  • Bladder Cancer
  • stage 0 bladder cancer
  • stage I bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms

Name

Location

West Virginia University HospitalsMorgantown, West Virginia  26506-9300