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Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

Thank you

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