Clinical trial NCT00389155: First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bladder Cancer
Transitional Cell Carcinoma
Metastasis
Keywords: Advanced or metastatic transitional cell carcinoma of the urothelium
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-10-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Secondary outcomes:
measure: Tumor Response Rate in Participants With A Best Response of Complete (CR) or Partial (PR) as Defined by RECIST criteria
timeFrame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
measure: Overall Survival of Participants With TCC of the Urothelium
timeFrame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
measure: Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD)
timeFrame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
measure: Duration of Response in Participants With Best Response of CR or PR
timeFrame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
measure: Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation
timeFrame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
measure: Number of Participants With Serum Chemistry Abnormalities by Worst Common Terminology Criteria (CTC) Grade
timeFrame: Following Day 1 to no longer than 30 days after last dose of study medication
measure: Number of Participants With Abnormal Laboratory Findings by Worst CTC Grade
timeFrame: Following Day 1 to no longer than 30 days after last dose of study medication
measure: Time to Response in Participants With Best Response of CR or PR
timeFrame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Tucson
country: United States
facility: Acrc/Arizona Clinical Research Center, Inc.
state: Arizona
city: Beverly Hills
country: United States
facility: Tower Hematology Oncology Medical Group
state: California
city: Concord
country: United States
facility: Local Institution
state: California
city: Glendale
country: United States
facility: Glendale Memorial Hospital And Health Center
state: California
city: La Jolla
country: United States
facility: Moores Ucsd Cancer Center
state: California
city: Mission Hills
country: United States
facility: North Valley Hematology/Oncology Medical Group
state: California
city: Orange
country: United States
facility: Local Institution
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Newark
country: United States
facility: Local Institution
state: Delaware
city: Jacksonville
country: United States
facility: University Of Florida College Of Medicine At Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Miami
country: United States
facility: University Of Miami
state: Florida
city: Miami
country: United States
facility: Advanced Medical Specialties
state: Florida
city: Augusta
country: United States
facility: Medical College Of Georgia
state: Georgia
city: Macon
country: United States
facility: Central Georgia Cancer Care, Pc
state: Georgia
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic, Llp
state: Illinois
city: South Bend
country: United States
facility: Michiana Hematology Oncology, P.C.
state: Indiana
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Troy
country: United States
facility: Mitchell Folbe, Md, Pc
state: Michigan
city: Minneapolis
country: United States
facility: Local Institution
state: Minnesota
city: Rochester
country: United States
facility: Local Institution
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Columbia
country: United States
facility: University Of Missouri Healthcare/Ellis Fischel Cancer Ctr
state: Missouri
city: Jefferson City
country: United States
facility: Capital Comprehensive Cancer Care Center
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Veterans Affairs Medical Center
state: Missouri
city: St. Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Billings
country: United States
facility: Hematology Oncology Centers Of The Northern Rockies, Pc
state: Montana
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Cancer Centers
state: Nevada
city: Hackensack
country: United States
facility: The Cancer Center At Hackensack University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Albert Einstein Cancer Center
state: New York
city: Cooperstown
country: United States
facility: The Mary Imogene Bassett Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: University Of Rochester
state: New York
city: Charlotte
country: United States
facility: Carolinas Hematology Oncology Associates
state: North Carolina
city: Bismarck
country: United States
facility: Mid Dakota Clinic, Pc
state: North Dakota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Mid-Ohio Oncology/Hematology, Inc. Dba
state: Ohio
city: Philadelphia
country: United States
facility: Abramson Cancer Center Of The
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Foundation For Education And Research
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
city: Germantown
country: United States
facility: The Jones Clinic, Pc
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Nashville
country: United States
facility: The Sarah Cannon Research Institute
state: Tennessee
city: Austin
country: United States
facility: Lone Star Oncology Consulants, Pa
state: Texas
city: Corpus Christi
country: United States
facility: Cancer Specialists Of South Texas, Pa
state: Texas
city: Fort Worth
country: United States
facility: The Center For Cancer And Blood Disorders
state: Texas
city: Galveston
country: United States
facility: University Of Texas Medical Branch Of Galveston
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology And Hematology, P.A.
state: Texas
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Abingdon
country: United States
facility: Cancer Outreach Associates, Pc
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Local Institution
state: Wisconsin
city: Tweed Heads
country: Australia
facility: Local Institution
state: New South Wales
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Antwerp
country: Belgium
facility: Local Institution
city: Edegem
country: Belgium
facility: Local Institution
city: Moncton
country: Canada
facility: Local Institution
state: New Brunswick
city: Sydney
country: Canada
facility: Local Institution
state: Nova Scotia
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Arhus
country: Denmark
facility: Local Institution
city: Herlev
country: Denmark
facility: Local Institution
city: Kobenhavn O
country: Denmark
facility: Local Institution
city: Odense C
country: Denmark
facility: Local Institution
city: Caen Cedex 05
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Jakarta
country: Indonesia
facility: Local Institution
city: Milan
country: Italy
facility: Local Institution
city: Trento
country: Italy
facility: Local Institution
city: Viterbo
country: Italy
facility: Local Institution
city: Seongnam
country: Korea, Republic of
facility: Local Institution
state: Gyeonggi-Do
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Cebu
country: Philippines
facility: Local Institution
city: Davao City
country: Philippines
facility: Local Institution
city: Manila
country: Philippines
facility: Local Institution
city: Quezon City
country: Philippines
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Cracow
country: Poland
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Olsztyn
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Warsaw
country: Poland
facility: Local Institution
city: Obninsk
country: Russian Federation
facility: Local Institution
state: Kaluga Region
city: Moscow
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: St Petersburg
country: Russian Federation
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Murcia
country: Spain
facility: Local Institution
city: Palma De Mallorca
country: Spain
facility: Local Institution
city: Sabadell (Barcelona)
country: Spain
facility: Local Institution
city: Santander
country: Spain
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Cardiff
country: United Kingdom
facility: Local Institution
state: Glamorgan
city: Grimsby
country: United Kingdom
facility: Local Institution
state: Lincolnshire
city: Nottingham
country: United Kingdom
facility: Local Institution
state: Nottinghamshire
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: