S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
- Registration Number
- NCT00234039
- Lead Sponsor
- SWOG Cancer Research Network
- 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 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intravesical Gemcitabine gemcitabine hydrochloride -
- Primary Outcome Measures
Name Time Method Complete Response Rate at the End of Induction 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
- Secondary Outcome Measures
Name Time Method Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug 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.
Overall Survival (OS) 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) 1 year Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause.
Trial Locations
- Locations (97)
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Cancer Centers of Central Florida, PA
🇺🇸Leesburg, Florida, United States
Hawaii Medical Center - East
🇺🇸Honolulu, Hawaii, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
Mercy General Health Partners
🇺🇸Muskegon, Michigan, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
🇺🇸Shreveport, Louisiana, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Wayne Hospital
🇺🇸Greenville, Ohio, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
U.T. Medical Center Cancer Institute
🇺🇸Knoxville, Tennessee, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Highland Clinic
🇺🇸Shreveport, Louisiana, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Bay Area Hospital
🇺🇸Coos Bay, Oregon, United States
Polyclinic First Hill
🇺🇸Seattle, Washington, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸New York, New York, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Columbia Basin Hematology
🇺🇸Kennewick, Washington, United States
University Hospital - San Antonio
🇺🇸San Antonio, Texas, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Minor and James Medical, PLLC
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Cancer Therapy and Research Center
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
Queen's Cancer Institute at Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini
🇺🇸Honolulu, Hawaii, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Kapiolani Medical Center at Pali Momi
🇺🇸Aiea, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana
🇺🇸Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated
🇺🇸Honolulu, Hawaii, United States
Olathe Cancer Center
🇺🇸Olathe, Kansas, United States
Rocky Mountain Oncology
🇺🇸Casper, Wyoming, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Maui Memorial Medical Center
🇺🇸Wailuku, Hawaii, United States
Pacific Cancer Institute - Maui
🇺🇸Wailuku, Hawaii, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Clinton Memorial Hospital
🇺🇸Wilmington, Ohio, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
🇺🇸Martinsville, Virginia, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Knight Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States