Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer - Full Text View

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00445601

Purpose

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	Intervention	Phase
Bladder Cancer	Drug: gemcitabine hydrochloride Other: placebo	Phase III

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Surgery

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Time to recurrence [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Worsening-free survival [ Designated as safety issue: No ]
Sensitivity and specificity of BTA Stat test [ Designated as safety issue: No ]
Sensitivity and specificity of NMP-22 Bladder Chek [ Designated as safety issue: No ]

Estimated Enrollment:	340
Study Start Date:	September 2007
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive intravesical gemcitabine hydrochloride over 1 hour.	Drug: gemcitabine hydrochloride Given intravesically
Arm II: Placebo Comparator Patients receive intravesical placebo over 1 hour.	Other: placebo Given intravesically

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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
At least 9 months since any prior bladder cancer resection before index tumor resection
No more than 2 recurrences (except for index tumor) within the 3 years 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, 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 6 months 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, ≤ 2 WBC/high-power field, and no rods or organisms on examination of spun urine sediment within the past 28 days
TURBT planned within the next 10 days

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 5 years

PRIOR CONCURRENT THERAPY:

More than 180 days since prior intravesical therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445601

Show 74 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
Investigator:	David P. Wood, MD	University of Michigan Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker )
Study ID Numbers:	CDR0000534235, SWOG-S0337
Study First Received:	March 7, 2007
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00445601 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

transitional cell carcinoma of the bladder
stage 0 bladder cancer
stage I bladder cancer
recurrent bladder cancer

Study placed in the following topic categories:

Antimetabolites
Urinary Tract Neoplasm
Cystocele
Immunologic Factors
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms

Immunosuppressive Agents
Antiviral Agents
Recurrence
Carcinoma
Radiation-Sensitizing Agents
Urologic Diseases
Bladder Neoplasm
Gemcitabine
Transitional Cell Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Enzyme Inhibitors
Urogenital Neoplasms

Urologic Neoplasms
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Urologic Diseases
Therapeutic Uses
Gemcitabine

ClinicalTrials.gov processed this record on May 06, 2009