First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389155
• Other study ID #: CA183-002
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 17, 2006
• Last updated: November 6, 2015
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: November 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma
• Carcinoma, Transitional Cell
• Metastasis
• Transitional Cell Carcinoma
• Urinary Bladder Neoplasms

Intervention

Drug:
• Vinflunine
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
• Gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration

Other:
• Placebo

Locations

Country	Name	City	State
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Tweed Heads	New South Wales
Belgium	Local Institution	Antwerp
Belgium	Local Institution	Edegem
Canada	Local Institution	London	Ontario
Canada	Local Institution	Moncton	New Brunswick
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Sydney	Nova Scotia
Denmark	Local Institution	Arhus
Denmark	Local Institution	Herlev
Denmark	Local Institution	Kobenhavn O
Denmark	Local Institution	Odense C
France	Local Institution	Caen Cedex 05
France	Local Institution	Paris Cedex 14
France	Local Institution	Vandoeuvre Les Nancy
Greece	Local Institution	Athens
Indonesia	Local Institution	Jakarta
Italy	Local Institution	Milan
Italy	Local Institution	Trento
Italy	Local Institution	Viterbo
Korea, Republic of	Local Institution	Seongnam	Gyeonggi-Do
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Philippines	Local Institution	Cebu
Philippines	Local Institution	Davao City
Philippines	Local Institution	Manila
Philippines	Local Institution	Quezon City
Poland	Local Institution	Bialystok
Poland	Local Institution	Cracow
Poland	Local Institution	Gdansk
Poland	Local Institution	Olsztyn
Poland	Local Institution	Poznan
Poland	Local Institution	Warsaw
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Obninsk	Kaluga Region
Russian Federation	Local Institution	Saint Petersburg
Russian Federation	Local Institution	St Petersburg
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Murcia
Spain	Local Institution	Palma De Mallorca
Spain	Local Institution	Sabadell (Barcelona)
Spain	Local Institution	Santander
Thailand	Local Institution	Bangkok
United Kingdom	Local Institution	Birmingham	West Midlands
United Kingdom	Local Institution	Cardiff	Glamorgan
United Kingdom	Local Institution	Grimsby	Lincolnshire
United Kingdom	Local Institution	Nottingham	Nottinghamshire
United States	Cancer Outreach Associates, Pc	Abingdon	Virginia
United States	Medical College Of Georgia	Augusta	Georgia
United States	Lone Star Oncology Consulants, Pa	Austin	Texas
United States	Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins	Baltimore	Maryland
United States	Tower Hematology Oncology Medical Group	Beverly Hills	California
United States	Billings Clinic	Billings	Montana
United States	Hematology Oncology Centers Of The Northern Rockies, Pc	Billings	Montana
United States	University Of Alabama At Birmingham	Birmingham	Alabama
United States	Mid Dakota Clinic, Pc	Bismarck	North Dakota
United States	Albert Einstein Cancer Center	Bronx	New York
United States	Charleston Cancer Center	Charleston	South Carolina
United States	Medical University Of South Carolina	Charleston	South Carolina
United States	Carolinas Hematology Oncology Associates	Charlotte	North Carolina
United States	University Of Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Missouri Cancer Associates	Columbia	Missouri
United States	University Of Missouri Healthcare/Ellis Fischel Cancer Ctr	Columbia	Missouri
United States	Mid-Ohio Oncology/Hematology, Inc. Dba	Columbus	Ohio
United States	Local Institution	Concord	California
United States	The Mary Imogene Bassett Hospital	Cooperstown	New York
United States	Cancer Specialists Of South Texas, Pa	Corpus Christi	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	The Center For Cancer And Blood Disorders	Fort Worth	Texas
United States	University Of Texas Medical Branch Of Galveston	Galveston	Texas
United States	The Jones Clinic, Pc	Germantown	Tennessee
United States	Glendale Memorial Hospital And Health Center	Glendale	California
United States	The Cancer Center At Hackensack University Medical Center	Hackensack	New Jersey
United States	Local Institution	Jacksonville	Florida
United States	University Of Florida College Of Medicine At Jacksonville	Jacksonville	Florida
United States	Capital Comprehensive Cancer Care Center	Jefferson City	Missouri
United States	Kansas City Veterans Affairs Medical Center	Kansas City	Missouri
United States	Moores Ucsd Cancer Center	La Jolla	California
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	Nevada Cancer Centers	Las Vegas	Nevada
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	Central Georgia Cancer Care, Pc	Macon	Georgia
United States	The West Clinic	Memphis	Tennessee
United States	Advanced Medical Specialties	Miami	Florida
United States	University Of Miami	Miami	Florida
United States	Local Institution	Milwaukee	Wisconsin
United States	Local Institution	Minneapolis	Minnesota
United States	North Valley Hematology/Oncology Medical Group	Mission Hills	California
United States	West Virginia University	Morgantown	West Virginia
United States	The Sarah Cannon Research Institute	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	New York Presbyterian Hospital	New York	New York
United States	Local Institution	Newark	Delaware
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Northern Utah Associates	Ogden	Utah
United States	Local Institution	Orange	California
United States	Abramson Cancer Center Of The	Philadelphia	Pennsylvania
United States	Local Institution	Rochester	Minnesota
United States	University Of Rochester	Rochester	New York
United States	South Texas Oncology And Hematology, P.A.	San Antonio	Texas
United States	Guthrie Foundation For Education And Research	Sayre	Pennsylvania
United States	Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Michiana Hematology Oncology, P.C.	South Bend	Indiana
United States	Springfield Clinic, Llp	Springfield	Illinois
United States	Washington University School Of Medicine	St. Louis	Missouri
United States	Stanford University	Stanford	California
United States	Mitchell Folbe, Md, Pc	Troy	Michigan
United States	Acrc/Arizona Clinical Research Center, Inc.	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  France,  Greece,  Indonesia,  Italy,  Korea, Republic of,  Philippines,  Poland,  Russian Federation,  Spain,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision	No
Secondary	Tumor Response Rate in Participants With A Best Response of Complete (CR) or Partial (PR) as Defined by RECIST criteria	Tumor response rate is defined as the number of participants in that arm whose best response is PR or CR, divided by the total number of randomized participants in the arm.	Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision	No
Secondary	Overall Survival of Participants With TCC of the Urothelium	Survival duration is defined as the time (in months) from randomization until death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive.	Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision	No
Secondary	Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD)	Disease control rate is defined as the number of participants in that arm whose best response is PR, CR, or SD, divided by the total number of randomized participants in the treatment arm.	Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision	No
Secondary	Duration of Response in Participants With Best Response of CR or PR	Duration of response is computed for participants with best response of CR or PR; the duration is measured from the time measurement criteria are met for CR or PR, whichever is recorded first, until the date of documented progressive disease or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment.	Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision	No
Secondary	Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation	An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event.	Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision	Yes
Secondary	Number of Participants With Serum Chemistry Abnormalities by Worst Common Terminology Criteria (CTC) Grade		Following Day 1 to no longer than 30 days after last dose of study medication	Yes
Secondary	Number of Participants With Abnormal Laboratory Findings by Worst CTC Grade		Following Day 1 to no longer than 30 days after last dose of study medication	Yes
Secondary	Time to Response in Participants With Best Response of CR or PR	Time to response is defined as the number of months from the first dose of study therapy until measurement criteria are met for PR or CR, whichever is recorded first.	Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm