Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG
18 Years
N/A
Both
Bladder Cancer
Trial Information
Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete Response Rate at the End of Induction
Outcome Description:
Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy
Outcome Time Frame:
Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5
Safety Issue:
No
Principal Investigator
Eila C. Skinner, MD
Investigator Role:
Study Chair
Investigator Affiliation:
USC/Norris Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000446074
NCT ID:
NCT00234039
Start Date:
November 2006
Completion Date:
February 2014
Related Keywords:
- Bladder Cancer
- recurrent bladder cancer
- stage 0 bladder cancer
- stage I bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
| Munson Medical Center | Traverse City, Michigan 49684 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
| Big Sky Oncology | Great Falls, Montana 59405 |
| St. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Regional Medical Center | Kalispell, Montana 59901 |
| Glacier Oncology, PLLC | Kalispell, Montana 59901 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
| Community Medical Center | Missoula, Montana 59801 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Olympic Hematology and Oncology | Bremerton, Washington 98310 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
| Harborview Medical Center | Seattle, Washington 98104 |
| Group Health Central Hospital | Seattle, Washington 98104 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
| University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
| Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
| Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
| Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
| Mecosta County Medical Center | Big Rapids, Michigan 49307 |
| Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
| Grandview Hospital | Dayton, Ohio 45405 |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
| Good Samaritan Hospital | Dayton, Ohio 45406 |
| Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
| Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
| Middletown Regional Hospital | Middletown, Ohio 45044 |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
| Cancer Therapy and Research Center | San Antonio, Texas 78229 |
| University Hospital - San Antonio | San Antonio, Texas 78229 |
| Minor and James Medical, PLLC | Seattle, Washington 98104 |
| Polyclinic First Hill | Seattle, Washington 98122 |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
| Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
| Billings Clinic - Downtown | Billings, Montana 59107-7000 |
| St. James Healthcare Cancer Care | Butte, Montana 59701 |
| Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
| Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
| Northern Montana Hospital | Havre, Montana 59501 |
| Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
| Wayne Hospital | Greenville, Ohio 45331 |
| Clinton Memorial Hospital | Wilmington, Ohio 45177 |
| St. Joseph Cancer Center | Bellingham, Washington 98225 |
| Columbia Basin Hematology | Kennewick, Washington 99336 |
| Rocky Mountain Oncology | Casper, Wyoming 82609 |
| Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
| Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
| Rutherford Hospital | Rutherfordton, North Carolina 28139 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
| Metro Health Hospital | Grand Rapids, Michigan 49506 |
| Great Falls, Montana 59405 | |
| Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
| St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
| Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
| Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
| Straub Clinic and Hospital, Incorporated | Honolulu, Hawaii 96813 |
| Hawaii Medical Center - East | Honolulu, Hawaii 96817 |
| OnCare Hawaii, Incorporated - Kuakini | Honolulu, Hawaii 96817 |
| OnCare Hawaii, Incorporated - Lusitana | Honolulu, Hawaii 96813 |
| Maui Memorial Medical Center | Wailuku, Hawaii 96793 |
| Pacific Cancer Institute - Maui | Wailuku, Hawaii 96793 |
| Mercy General Health Partners | Muskegon, Michigan 49443 |
| Bay Area Hospital | Coos Bay, Oregon 97420 |
| AnMed Cancer Center | Anderson, South Carolina 29621 |
| U.T. Medical Center Cancer Institute | Knoxville, Tennessee 37920-6999 |
| Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia 24115 |
| Highland Clinic | Shreveport, Louisiana 71105 |
| Olathe Cancer Center | Olathe, Kansas 66061 |
| Cancer Centers of Central Florida, PA | Leesburg, Florida 34788 |
