Bladder Cancer Clinical Trial
Official title:
Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG
Verified date | December 2015 |
Source | Southwest Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 58 |
Est. completion date | April 2013 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Kapiolani Medical Center at Pali Momi | Aiea | Hawaii |
United States | McDowell Cancer Center at Akron General Medical Center | Akron | Ohio |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | AnMed Cancer Center | Anderson | South Carolina |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan |
United States | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana |
United States | St. Joseph Cancer Center | Bellingham | Washington |
United States | Mecosta County Medical Center | Big Rapids | Michigan |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana |
United States | Northern Rockies Radiation Oncology Center | Billings | Montana |
United States | St. Vincent Healthcare Cancer Care Services | Billings | Montana |
United States | Olympic Hematology and Oncology | Bremerton | Washington |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Rocky Mountain Oncology | Casper | Wyoming |
United States | Bay Area Hospital | Coos Bay | Oregon |
United States | CCOP - Dayton | Dayton | Ohio |
United States | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Samaritan North Cancer Care Center | Dayton | Ohio |
United States | Veterans Affairs Medical Center - Dayton | Dayton | Ohio |
United States | Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan |
United States | Blanchard Valley Medical Associates | Findlay | Ohio |
United States | Middletown Regional Hospital | Franklin | Ohio |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | CCOP - Grand Rapids | Grand Rapids | Michigan |
United States | Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan |
United States | Big Sky Oncology | Great Falls | Montana |
United States | Great Falls Clinic - Main Facility | Great Falls | Montana |
United States | Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana |
United States | Wayne Hospital | Greenville | Ohio |
United States | Northern Montana Hospital | Havre | Montana |
United States | St. Peter's Hospital | Helena | Montana |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Hawaii Medical Center - East | Honolulu | Hawaii |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | OnCare Hawaii, Incorporated - Kuakini | Honolulu | Hawaii |
United States | OnCare Hawaii, Incorporated - Lusitana | Honolulu | Hawaii |
United States | Queen's Cancer Institute at Queen's Medical Center | Honolulu | Hawaii |
United States | Straub Clinic and Hospital, Incorporated | Honolulu | Hawaii |
United States | Tripler Army Medical Center | Honolulu | Hawaii |
United States | Glacier Oncology, PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology at KRMC | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas |
United States | Columbia Basin Hematology | Kennewick | Washington |
United States | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | U.T. Medical Center Cancer Institute | Knoxville | Tennessee |
United States | Cancer Centers of Central Florida, PA | Leesburg | Florida |
United States | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville | Virginia |
United States | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois |
United States | Community Medical Center | Missoula | Montana |
United States | Guardian Oncology and Center for Wellness | Missoula | Montana |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Mercy General Health Partners | Muskegon | Michigan |
United States | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York |
United States | Olathe Cancer Center | Olathe | Kansas |
United States | Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon |
United States | Reid Hospital & Health Care Services | Richmond | Indiana |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah |
United States | Cancer Therapy and Research Center | San Antonio | Texas |
United States | University Hospital - San Antonio | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Group Health Central Hospital | Seattle | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Minor and James Medical, PLLC | Seattle | Washington |
United States | Polyclinic First Hill | Seattle | Washington |
United States | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington |
United States | University Cancer Center at University of Washington Medical Center | Seattle | Washington |
United States | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming |
United States | Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport | Louisiana |
United States | Highland Clinic | Shreveport | Louisiana |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | Cancer Care Northwest - Spokane South | Spokane | Washington |
United States | Regional Cancer Center at Memorial Medical Center | Springfield | Illinois |
United States | CCOP - Scott and White Hospital | Temple | Texas |
United States | Munson Medical Center | Traverse City | Michigan |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | Maui Memorial Medical Center | Wailuku | Hawaii |
United States | Pacific Cancer Institute - Maui | Wailuku | Hawaii |
United States | Clinton Memorial Hospital | Wilmington | Ohio |
United States | Metro Health Hospital | Wyoming | Michigan |
United States | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Response Rate at the End of Induction | Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy | Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5 | No |
Secondary | Overall Survival (OS) | Measured from the day of registration to death due to any cause. Survival is censored at date of last contact. | 1 year | No |
Secondary | Recurrence-free Survival (RFS) | Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause. | 1 year | No |
Secondary | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | 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. | Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks | Yes |
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