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Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
gemcitabine hydrochloride
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage 0 bladder cancer, stage I bladder cancer, recurrent bladder cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 10, 2001
    Last Updated
    December 18, 2013
    Sponsor
    University of Pittsburgh
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00014287
    Brief Title
    Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer
    Official Title
    Intravesical Gemcitabine Therapy for BCG-Refractory Superficial Bladder Cancer: A Phase I and Pharmacokinetic Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    September 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pittsburgh
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of gemcitabine given directly into the bladder in treating patients who have recurrent or refractory bladder cancer.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bladder Cancer
    Keywords
    stage 0 bladder cancer, stage I bladder cancer, recurrent bladder cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    gemcitabine hydrochloride

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Donald L. Trump, MD
    Organizational Affiliation
    University of Pittsburgh
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer

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