S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
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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: NCT00234039 |
Recruitment Status :
Completed
First Posted : October 6, 2005
Results First Posted : December 18, 2012
Last Update Posted : January 8, 2016
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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).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bladder Cancer | Drug: gemcitabine hydrochloride | Phase 2 |
OBJECTIVES:
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 58 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG |
Study Start Date : | November 2006 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | April 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Intravesical Gemcitabine |
Drug: gemcitabine hydrochloride |
- 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
- 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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Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- Prior intravesical interferon alfa allowed, alone or in combination with Bacillus Calmette-Guerin (BCG)
Chemotherapy
- 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
Radiotherapy
- No prior pelvic radiotherapy
- No concurrent radiotherapy to any other area of the body
Surgery
- See Disease Characteristics
- Recovered from prior surgery

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): NCT00234039

United States, Arkansas | |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90089-9181 | |
United States, Florida | |
Cancer Centers of Central Florida, PA | |
Leesburg, Florida, United States, 34788 | |
United States, Hawaii | |
Kapiolani Medical Center at Pali Momi | |
Aiea, Hawaii, United States, 96701 | |
Cancer Research Center of Hawaii | |
Honolulu, Hawaii, United States, 96813 | |
OnCare Hawaii, Incorporated - Lusitana | |
Honolulu, Hawaii, United States, 96813 | |
Queen's Cancer Institute at Queen's Medical Center | |
Honolulu, Hawaii, United States, 96813 | |
Straub Clinic and Hospital, Incorporated | |
Honolulu, Hawaii, United States, 96813 | |
Hawaii Medical Center - East | |
Honolulu, Hawaii, United States, 96817 | |
OnCare Hawaii, Incorporated - Kuakini | |
Honolulu, Hawaii, United States, 96817 | |
Kapiolani Medical Center for Women and Children | |
Honolulu, Hawaii, United States, 96826 | |
Tripler Army Medical Center | |
Honolulu, Hawaii, United States, 96859 | |
Maui Memorial Medical Center | |
Wailuku, Hawaii, United States, 96793 | |
Pacific Cancer Institute - Maui | |
Wailuku, Hawaii, United States, 96793 | |
United States, Illinois | |
Decatur Memorial Hospital Cancer Care Institute | |
Decatur, Illinois, United States, 62526 | |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
Regional Cancer Center at Memorial Medical Center | |
Springfield, Illinois, United States, 62781-0001 | |
United States, Indiana | |
St. Francis Hospital and Health Centers - Beech Grove Campus | |
Beech Grove, Indiana, United States, 46107 | |
Reid Hospital & Health Care Services | |
Richmond, Indiana, United States, 47374 | |
United States, Kansas | |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160-7357 | |
Olathe Cancer Center | |
Olathe, Kansas, United States, 66061 | |
United States, Louisiana | |
Highland Clinic | |
Shreveport, Louisiana, United States, 71105 | |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | |
Shreveport, Louisiana, United States, 71130-3932 | |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109-0942 | |
Battle Creek Health System Cancer Care Center | |
Battle Creek, Michigan, United States, 49017 | |
Mecosta County Medical Center | |
Big Rapids, Michigan, United States, 49307 | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
Josephine Ford Cancer Center at Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
Butterworth Hospital at Spectrum Health | |
Grand Rapids, Michigan, United States, 49503 | |
CCOP - Grand Rapids | |
Grand Rapids, Michigan, United States, 49503 | |
Lacks Cancer Center at Saint Mary's Health Care | |
Grand Rapids, Michigan, United States, 49503 | |
Mercy General Health Partners | |
Muskegon, Michigan, United States, 49443 | |
Munson Medical Center | |
Traverse City, Michigan, United States, 49684 | |
Metro Health Hospital | |
Wyoming, Michigan, United States, 49519 | |
United States, Montana | |
CCOP - Montana Cancer Consortium | |
Billings, Montana, United States, 59101 | |
Hematology-Oncology Centers of the Northern Rockies - Billings | |
Billings, Montana, United States, 59101 | |
Northern Rockies Radiation Oncology Center | |
Billings, Montana, United States, 59101 | |
St. Vincent Healthcare Cancer Care Services | |
Billings, Montana, United States, 59101 | |
Billings Clinic - Downtown | |
Billings, Montana, United States, 59107-7000 | |
St. James Healthcare Cancer Care | |
Butte, Montana, United States, 59701 | |
Big Sky Oncology | |
Great Falls, Montana, United States, 59405-5309 | |
Great Falls Clinic - Main Facility | |
Great Falls, Montana, United States, 59405 | |
Sletten Cancer Institute at Benefis Healthcare | |
Great Falls, Montana, United States, 59405 | |
Great Falls, Montana, United States, 59405 | |
Northern Montana Hospital | |
Havre, Montana, United States, 59501 | |
St. Peter's Hospital | |
Helena, Montana, United States, 59601 | |
Glacier Oncology, PLLC | |
Kalispell, Montana, United States, 59901 | |
Kalispell Medical Oncology at KRMC | |
Kalispell, Montana, United States, 59901 | |
Kalispell Regional Medical Center | |
Kalispell, Montana, United States, 59901 | |
Community Medical Center | |
Missoula, Montana, United States, 59801 | |
Guardian Oncology and Center for Wellness | |
Missoula, Montana, United States, 59804 | |
Montana Cancer Specialists at Montana Cancer Center | |
Missoula, Montana, United States, 59807-7877 | |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
Missoula, Montana, United States, 59807 | |
United States, New Mexico | |
University of New Mexico Cancer Center | |
Albuquerque, New Mexico, United States, 87131-5636 | |
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
New York, New York, United States, 10032 | |
James P. Wilmot Cancer Center at University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, North Carolina | |
Wayne Memorial Hospital, Incorporated | |
Goldsboro, North Carolina, United States, 27534 | |
Rutherford Hospital | |
Rutherfordton, North Carolina, United States, 28139 | |
United States, Ohio | |
McDowell Cancer Center at Akron General Medical Center | |
Akron, Ohio, United States, 44307 | |
Grandview Hospital | |
Dayton, Ohio, United States, 45405 | |
Good Samaritan Hospital | |
Dayton, Ohio, United States, 45406 | |
David L. Rike Cancer Center at Miami Valley Hospital | |
Dayton, Ohio, United States, 45409 | |
Samaritan North Cancer Care Center | |
Dayton, Ohio, United States, 45415 | |
Veterans Affairs Medical Center - Dayton | |
Dayton, Ohio, United States, 45428 | |
CCOP - Dayton | |
Dayton, Ohio, United States, 45429 | |
Blanchard Valley Medical Associates | |
Findlay, Ohio, United States, 45840 | |
Middletown Regional Hospital | |
Franklin, Ohio, United States, 45005-1066 | |
Wayne Hospital | |
Greenville, Ohio, United States, 45331 | |
Charles F. Kettering Memorial Hospital | |
Kettering, Ohio, United States, 45429 | |
UVMC Cancer Care Center at Upper Valley Medical Center | |
Troy, Ohio, United States, 45373-1300 | |
Clinton Memorial Hospital | |
Wilmington, Ohio, United States, 45177 | |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
Xenia, Ohio, United States, 45385 | |
United States, Oregon | |
Bay Area Hospital | |
Coos Bay, Oregon, United States, 97420 | |
Knight Cancer Institute at Oregon Health and Science University | |
Portland, Oregon, United States, 97239-3098 | |
United States, South Carolina | |
AnMed Cancer Center | |
Anderson, South Carolina, United States, 29621 | |
CCOP - Upstate Carolina | |
Spartanburg, South Carolina, United States, 29303 | |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
Spartanburg, South Carolina, United States, 29303 | |
United States, Tennessee | |
U.T. Medical Center Cancer Institute | |
Knoxville, Tennessee, United States, 37920-6999 | |
United States, Texas | |
Veterans Affairs Medical Center - San Antonio (Murphy) | |
San Antonio, Texas, United States, 78209 | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78229-3900 | |
Cancer Therapy and Research Center | |
San Antonio, Texas, United States, 78229 | |
University Hospital - San Antonio | |
San Antonio, Texas, United States, 78229 | |
CCOP - Scott and White Hospital | |
Temple, Texas, United States, 76508 | |
United States, Utah | |
Huntsman Cancer Institute at University of Utah | |
Salt Lake City, Utah, United States, 84112 | |
United States, Virginia | |
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | |
Martinsville, Virginia, United States, 24115 | |
United States, Washington | |
St. Joseph Cancer Center | |
Bellingham, Washington, United States, 98225 | |
Olympic Hematology and Oncology | |
Bremerton, Washington, United States, 98310 | |
Columbia Basin Hematology | |
Kennewick, Washington, United States, 99336 | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98104 | |
Harborview Medical Center | |
Seattle, Washington, United States, 98104 | |
Minor and James Medical, PLLC | |
Seattle, Washington, United States, 98104 | |
Group Health Central Hospital | |
Seattle, Washington, United States, 98112 | |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
Seattle, Washington, United States, 98122-4307 | |
Polyclinic First Hill | |
Seattle, Washington, United States, 98122 | |
University Cancer Center at University of Washington Medical Center | |
Seattle, Washington, United States, 98195-6043 | |
Cancer Care Northwest - Spokane South | |
Spokane, Washington, United States, 99202 | |
United States, Wyoming | |
Rocky Mountain Oncology | |
Casper, Wyoming, United States, 82609 | |
Welch Cancer Center at Sheridan Memorial Hospital | |
Sheridan, Wyoming, United States, 82801 |
Study Chair: | Eila C. Skinner, MD | University of Southern California |
Responsible Party: | Southwest Oncology Group |
ClinicalTrials.gov Identifier: | NCT00234039 History of Changes |
Other Study ID Numbers: |
CDR0000446074 U10CA032102 ( U.S. NIH Grant/Contract ) S0353 ( Other Identifier: SWOG ) |
First Posted: | October 6, 2005 Key Record Dates |
Results First Posted: | December 18, 2012 |
Last Update Posted: | January 8, 2016 |
Last Verified: | December 2015 |
recurrent bladder cancer stage 0 bladder cancer stage I bladder cancer transitional cell carcinoma of the bladder |
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 |