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Intravesical Gemcitabine Therapy for BCG-Refractory Superficial Bladder Cancer: A Phase I and Pharmacokinetic Study

Phase 1
18 Years
Not Enrolling
Bladder Cancer

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Trial Information

Intravesical Gemcitabine Therapy for BCG-Refractory Superficial Bladder Cancer: A Phase I and Pharmacokinetic Study

OBJECTIVES: I. Determine the maximum tolerated dose of intravesical gemcitabine in patients
with recurrent or refractory superficial bladder cancer. II. Determine the dose-limiting
toxicity and other toxic effects of this regimen in these patients. III. Assess any
responses in patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study. Patients receive intravesical
gemcitabine that is left in the bladder for 2 hours and then removed on day 1. Treatment
continues every 7 days for 6 courses in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of intravesical gemcitabine until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed
every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage Tis, Ta, or T1 bladder carcinoma
No stage B1 disease or greater No locally invasive or metastatic disease by CT or MRI No
upper urinary tract disease Measurable persistent or recurrent superficial disease after
standard treatment with intravesical BCG Stage Tis disease must fail second course of BCG
if complete response achieved with first course of BCG Prior maximal transurethral
resection High-grade T1 or Tis disease must be ineligible for cystectomy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL
AST no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5
mg/dL Other: Not pregnant Negative pregnancy test Fertile patients must use effective
contraception for 1 week prior to, during, and for at least 2 weeks after study No active
bacterial infection requiring treatment with antibiotics

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks
since prior immunotherapy Chemotherapy: Prior intravesical chemotherapy allowed At least 4
weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4
weeks since prior radiotherapy No prior radiotherapy to bladder Surgery: See Disease
Characteristics At least 2 weeks since prior transurethral resection of the
bladder/bladder biopsy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Donald L. Trump, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh


United States: Federal Government

Study ID:




Start Date:

September 2000

Completion Date:

Related Keywords:

  • Bladder Cancer
  • stage 0 bladder cancer
  • stage I bladder cancer
  • recurrent bladder cancer
  • Urinary Bladder Neoplasms



University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410