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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 CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
USC/Norris Comprehensive Cancer Center and HospitalLos 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 SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Mecosta County Medical CenterBig Rapids, Michigan  49307
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Cancer Therapy and Research CenterSan Antonio, Texas  78229
University Hospital - San AntonioSan Antonio, Texas  78229
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Billings Clinic - DowntownBillings, Montana  59107-7000
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Wayne HospitalGreenville, Ohio  45331
Clinton Memorial HospitalWilmington, Ohio  45177
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Rocky Mountain OncologyCasper, Wyoming  82609
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Straub Clinic and Hospital, IncorporatedHonolulu, Hawaii  96813
Hawaii Medical Center - EastHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
Maui Memorial Medical CenterWailuku, Hawaii  96793
Pacific Cancer Institute - MauiWailuku, Hawaii  96793
Mercy General Health PartnersMuskegon, Michigan  49443
Bay Area HospitalCoos Bay, Oregon  97420
AnMed Cancer CenterAnderson, South Carolina  29621
U.T. Medical Center Cancer InstituteKnoxville, Tennessee  37920-6999
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry CountyMartinsville, Virginia  24115
Highland ClinicShreveport, Louisiana  71105
Olathe Cancer CenterOlathe, Kansas  66061
Cancer Centers of Central Florida, PALeesburg, Florida  34788