S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234039
Recruitment Status : Completed
First Posted : October 6, 2005
Results First Posted : December 18, 2012
Last Update Posted : January 8, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

October 5, 2005
October 6, 2005
November 19, 2012
December 18, 2012
January 8, 2016
November 2006
November 2011   (Final data collection date for primary outcome measure)
Complete Response Rate at the End of Induction [ Time Frame: Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5 ]
Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy
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Complete list of historical versions of study NCT00234039 on Archive Site
  • Overall Survival (OS) [ Time Frame: 1 year ]
    Measured from the day of registration to death due to any cause. Survival is censored at date of last contact.
  • Recurrence-free Survival (RFS) [ Time Frame: 1 year ]
    Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause.
  • Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks ]
    Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
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S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine directly into the bladder may kill more tumor cells.

PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with recurrent bladder cancer that has progressed despite previous Bacillus Calmette-Guerin (BCG).


  • Determine the 8-12 week efficacy of intravesical gemcitabine, in terms of complete response rate, in patients with recurrent superficial transitional cell carcinoma of the bladder that have progressed despite prior intravesical Bacillus Calmette-Guerin (BCG).
  • Determine the recurrence-free, worsening-free, progression-free, and overall survival of patients treated with this drug.
  • Evaluate the toxicity of this drug in these patients.
  • Correlate, preliminarily, expression levels of genes or genetic polymorphisms involved in the gemcitabine pathway and angiogenesis with clinical toxicity, response, and relapse-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive gemcitabine intravesically once a week for 6 weeks (weeks 1-6) in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response proceed to maintenance therapy at week 14.
  • Maintenance therapy: Patients receive gemcitabine intravesically once in weeks 14, 18, 22, 26, 30, 34, 38, 42, 46, and 50 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 6-12 months.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bladder Cancer
Drug: gemcitabine hydrochloride
Experimental: Intravesical Gemcitabine
Intervention: Drug: gemcitabine hydrochloride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2013
November 2011   (Final data collection date for primary outcome measure)


  • Histologically confirmed superficial transitional cell carcinoma (TCC) of the bladder meeting 1 of the following stage criteria:

    • Stage T1, grade 2-3
    • Stage Tis
    • Stage Ta, grade 3-4 or multifocal (> 2 lesions)
  • Must have received and failed ≥ 2 courses of intravesical Bacillus Calmette-Guerin (BCG) (one 6-week course, plus one 3-week course, or fewer weeks if BCG was discontinued due to side effects) within the past 3 years
  • Recurrent disease

    • Must have had a transurethral resection of the bladder tumor (TURBT) or bladder biopsy within the past 60 days documenting tumor recurrence and tumor stage and grade

      • TURBT or biopsy must have been performed ≥ 6 weeks after the completion of BCG and/or other immunotherapy treatment (or ≥ 14 days after completion of intravesical chemotherapy treatment)
      • All visible tumor must have been resected at the time of the last biopsy
  • No evidence of urethral or renal pelvis TCC by upper tract radiological imaging (e.g., intravenous pyelogram, CT urogram, or retrograde pyelogram) within the past 2 years



  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


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  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is in complete remission


Biologic therapy

  • See Disease Characteristics
  • Prior intravesical interferon alfa allowed, alone or in combination with Bacillus Calmette-Guerin (BCG)


  • See Disease Characteristics
  • No more than 1 course of intravesical chemotherapy (e.g., thiotepa, mitomycin, or doxorubicin) within the past year, defined as 6 or more weekly instillations, with or without monthly maintenance instillations
  • No prior gemcitabine

Endocrine therapy

  • Not specified


  • No prior pelvic radiotherapy
  • No concurrent radiotherapy to any other area of the body


  • See Disease Characteristics
  • Recovered from prior surgery
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
U10CA032102 ( U.S. NIH Grant/Contract )
S0353 ( Other Identifier: SWOG )
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Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Eila C. Skinner, MD University of Southern California
Southwest Oncology Group
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP