ClinicalTrials.gov
ClinicalTrials.gov Menu

S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer

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.
ClinicalTrials.gov Identifier: NCT00445601
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

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 after surgery may kill more tumor cells. It is not yet known whether giving gemcitabine directly into the bladder is more effective than a placebo in treating bladder cancer.

PURPOSE: This randomized phase III trial is studying gemcitabine to see how well it works when given directly into the bladder compared with a placebo after surgery in treating patients with newly diagnosed or recurrent bladder cancer.


Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: gemcitabine hydrochloride Other: placebo Phase 3

Detailed Description:

OBJECTIVES:

Primary

  • Compare the efficacy of a single intravesical instillation of gemcitabine hydrochloride vs placebo immediately after transurethral resection of the bladder tumor (TURBT) in preventing recurrence at 2 years in patients with grade 1 or 2 superficial transitional cell cancer of the bladder.

Secondary

  • Compare whether a single instillation of intravesical gemcitabine hydrochloride can improve the time to progression to muscle invasive disease vs placebo in these patients.
  • Compare the qualitative and quantitative toxicities of these regimens in these patients.
  • Compare whether treatment with post-TURBT intravesical instillation of gemcitabine vs placebo results in reduced long-term morbidity in patients, as defined by requirement for fewer TURBTs, courses of traditional intravesical therapies, and surveillance cystoscopies over 4 years.

Tertiary

  • Assess whether performing a combination of molecular and/or cytologic diagnostic marker tests, including NMP-22 Bladder Chek and BTA Stat every 3 months, can predict recurrence as accurately as cystoscopy alone in these patients.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to disease status (first occurrence vs recurrent disease) and number of tumor sites (1 vs ≥ 2). Patients are randomized to 1 of 2 treatment arms.

All patients undergo transurethral resection of the bladder tumor. Within 3 hours, patients receive intravesical therapy according to their randomized arm.

  • Arm I: Patients receive intravesical gemcitabine hydrochloride over 1 hour.
  • Arm II: Patients receive intravesical placebo over 1 hour. Urine is collected at baseline and then every 3 months for 2 years for research studies including the NMP-22 Bladder Chek and BTA Stat test.

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

PROJECTED ACCRUAL: A total of 340 patients will be accrued for this study.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Blinded Study of Immediate Post TURBT Instillation of Gemcitabine Versus Saline in Patients With Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer
Study Start Date : September 2007
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: Arm I
Patients receive intravesical gemcitabine hydrochloride over 1 hour.
Drug: gemcitabine hydrochloride
Given intravesically
Placebo Comparator: Arm II
Patients receive intravesical placebo over 1 hour.
Other: placebo
Given intravesically



Primary Outcome Measures :
  1. Disease Recurrence Rate [ Time Frame: Up to 2 Years ]
    Percentage of patients who experienced a recurrence of grade 1 or 2 superficial transitional cell cancer of the bladder between the date of registration and 24 months. Disease recurrence considered to occur at date of first observation of recurrent disease subsequently confirmed by biopsy. Patients without recurrence were censored at the time of their last cystoscopy.


Secondary Outcome Measures :
  1. Rate of Progression to Muscle Invasive Disease at 4 Years [ Time Frame: 4 years ]
    From date of registration to date of diagnosis of progressive disease. Censor at date of last disease assessment for those without progression.

  2. Compare Qualitative and Quantitative Toxicities Between the Treatment Arms [ Time Frame: Up to 4 years after Transurethral Resection of Bladder Tumor (TURBT) ]
    Number of patients with Grade 3 through Grade 5 adverse events that are related to study drug

  3. Rate of Disease Worsening Over 2 Years [ Time Frame: Up to 2 years ]
    Compare whether treatment with post-TURBT intravesical instillation of gemcitabine vs placebo results in reduced long-term morbidity in patients, as defined by requirement for fewer TURBTs, courses of traditional intravesical therapies, and surveillance cystoscopies over 4 years.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of newly diagnosed or recurrent transitional cell bladder cancer meeting the following criteria:

    • Ta or T1 primary tumor
    • Grade 1 or 2 disease
  • No more than 2 recurrences (except for index tumor) within the 18 months prior to the index tumor's transurethral resection of the bladder tumor (TURBT)

    • Index tumor post-TURBT must meet the following criteria:

      • Ta or T1 tumor without any prior tumor in situ, grade 3 (high grade) disease within 2 years prior to index tumor TURBT, or invasion of the muscularis propria (stage ≥ T2)
      • Grade 1 or 2 disease (similar to papillary urothelial neoplasm of low malignant potential and low-grade bladder cancer)
  • Not a candidate for a therapy other than TURBT (e.g., a series of instillations of intravesical immunotherapy [e.g., BCG] or intravesical chemotherapy, or cystectomy or partial cystectomy)
  • Negative upper tract imaging studies within 1 year (365 days) prior to study entry

    • Imaging studies may be performed after registration provided it is done prior to TURBT on the day of treatment
  • No urothelial cancer of the prostate or more distal urethra (or urethra at all in women) as assessed by endoscopy
  • Must have a negative urine culture (less than or equal to 10,000 col/mL, mixed flora-likely contamination) OR negative urine analysis for infection AND negative nitrates on reagent strip, ≤ 10 white blood cell count (WBC)/high-power field, and no rods or organisms on examination of spun urine sediment OR an automated or visual reagent strip urinalysis that is negative for leukocytes and nitrates within the past 28 days
  • TURBT planned within the next 28 days and planned treatment within 3 hours after TURBT

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior malignancy except for any of the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • In situ cervical cancer
    • Adequately treated stage I or II cancer from which patient is in complete remission
    • Any other cancer from which patient has been disease-free for 3 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 145 days since prior intravesical therapy

Information from the National Library of Medicine

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): NCT00445601


  Show 70 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Edward M. Messing, MD, FACS James P. Wilmot Cancer Center
Study Chair: Deepak M. Sahasrabudhe, MD James P. Wilmot Cancer Center
Study Chair: Theresa M. Koppie, MD Oregon Health and Science University
Study Chair: David P. Wood, MD Beaumont Physician Partners
  Study Documents (Full-Text)

Documents provided by Southwest Oncology Group:

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00445601     History of Changes
Other Study ID Numbers: CDR0000534235
S0337 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2007    Key Record Dates
Results First Posted: April 24, 2018
Last Update Posted: April 24, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Southwest Oncology Group:
transitional cell carcinoma of the bladder
stage 0 bladder cancer
stage I bladder cancer
recurrent bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs