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A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Carcinoma, Metastasis

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Trial Information

A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy


Inclusion Criteria:



- Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally
advanced or metastatic

- Ineligible for cisplatin-based therapy because of at least one of the following two
medical conditions:

- Calculated creatinine clearance ≤60 mL/min: OR

- New York Heart Association Classification Stage III-IV Congestive Heart Failure

- Measurable disease documented by imaging with at least one uni-dimensional lesion

- Adequate performance status (ECOG 0, 1, or 2)

- Men and women ≥18 years of age

Exclusion Criteria:

- Patients in whom radiation or surgery is indicated

- Current neuropathy ≥ CTCAE grade 3

- Prior radiation to ≥ 30% of bone marrow

- Inadequate renal function: serum creatinine clearance ≤ 20 mL/min

- Prior allergy to any vinca alkaloid

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Median Progression-free Survival (PFS) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria in Participants With Advanced Transitional Cell Carcinoma (TCC) of the Urothelium

Outcome Description:

PFS survival is defined as the time between randomization and the date of progression or death, whichever occurs first, before or after treatment discontinuation. For those still on study and those who remain alive and have not progressed after treatment discontinuation, PFS will be censored on the date of the last tumor assessment.

Outcome Time Frame:

Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA183-002

NCT ID:

NCT00389155

Start Date:

January 2007

Completion Date:

January 2008

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Carcinoma
  • Metastasis
  • Advanced or metastatic transitional cell carcinoma of the urothelium
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Neoplasm Metastasis

Name

Location

Washington University School of Medicine Saint Louis, Missouri  63110
Medical University of South Carolina Charleston, South Carolina  29425-0721
Henry Ford Hospital Detroit, Michigan  48202
Glendale Memorial Hospital and Health Center Glendale, California  91204
Stanford University Stanford, California  94305
James Graham Brown Cancer Center Louisville, Kentucky  40202
Virginia Mason Medical Center Seattle, Washington  98111
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Virginia Oncology Associates Newport News, Virginia  23606
Moores UCSD Cancer Center La Jolla, California  92093-0658
Missouri Cancer Associates Columbia, Missouri  65201
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Medical College of Georgia Augusta, Georgia  30912
Tower Hematology Oncology Medical Group Los Angeles, California  90048
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
University of Rochester Rochester, New York  14642
Northern Utah Associates Ogden, Utah  84403
Albert Einstein Cancer Center Bronx, New York  10461
Cleveland Clinic Cleveland, Ohio  44195
Lakeland Regional Cancer Center Lakeland, Florida  33805
Charleston Cancer Center Charleston, South Carolina  29406
University of Chicago Chicago, Illinois  60637
Local Institution Green Bay, Wisconsin  
ACRC/Arizona Clinical Research Center, Inc. Tucson, Arizona  85712
North Valley Hematology/Oncology Medical Group Northridge, California  91328
University of Miami Miami, Florida  33136
Local Institution Corona, California  
Local Institution Fort Lauderdale, Florida  
Local Institution Duluth, Minnesota  
The Center for Cancer and Blood Disorders Fort Worth, Texas  76104
New York Presbyterian Hospital New York, New York  10021
Cancer Specialists of South Texas, PA Corpus Christi, Texas  78412
The West Clinic Memphis, Tennessee  38120
The Mary Imogene Bassett Hospital Cooperstown, New York  13326
Nevada Cancer Institute Las Vegas, Nevada  89135
Guthrie Foundation for Education and Research Sayre, Pennsylvania  18840
Kansas City Veterans Affairs Medical Center Kansas City, Missouri  64128
Billings Clinic Billings, Montana  59107-7000
Columbia University Medical Center New York, New York  10032
West Virginia University Morgantown, West Virginia  26506
Nevada Cancer Centers Las Vegas, Nevada  89109
The Cancer Center at Hackensack University Medical Center Hackensack, New Jersey  07601
Abramson Cancer Center of the Philadelphia, Pennsylvania  19104-4283
Springfield Clinic, LLP Springfield, Illinois  62703
Mitchell Folbe, MD, PC Troy, Michigan  48085
The Sarah Cannon Research Institute Nashville, Tennessee  37203
Cancer Outreach Associates, PC Abingdon, Virginia  24211
South Texas Oncology and Hematology, P.A. San Antonio, Texas  78207
Local Institution Newark, Delaware  
Central Georgia Cancer Care, PC Macon, Georgia  31201
Advanced Medical Specialties Miami, Florida  33176
Hematology Oncology Centers of the Northern Rockies, PC Billings, Montana  59101
Carolinas Hematology Oncology Associates Charlotte, North Carolina  28203
University Of Florida College Of Medicine At Jacksonville Jacksonville, Florida  32209
Michiana Hematology Oncology, P.C. South Bend, Indiana  46601
University Of Missouri Healthcare/Ellis Fischel Cancer Ctr Columbia, Missouri  65203
Capital Comprehensive Cancer Care Center Jefferson City, Missouri  65109
Mid-Ohio Oncology/Hematology, Inc. Dba Columbus, Ohio  43219
The Jones Clinic, Pc Germantown, Tennessee  38138
Lone Star Oncology Consulants, Pa Austin, Texas  78759
University Of Texas Medical Branch Of Galveston Galveston, Texas  77555
Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr Seattle, Washington  98195