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

NCT00389155 | Completed Phase 2 DMC

• 1 other identifier: CA183-002
• Study Type: interventional
• Target: 34
• Locations: 16 countries
• Sites: 112

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.

Conditions

Bladder Cancer; Transitional Cell Carcinoma; Metastasis

Keywords

Advanced or metastatic transitional cell carcinoma of the urothelium

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Tumor Response Rate in Participants With A Best Response of Complete (CR) or Partial (PR) as Defined by RECIST criteria

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

• Overall Survival of Participants With TCC of the Urothelium

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

• Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD)

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

• Duration of Response in Participants With Best Response of CR or PR

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

• Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation

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

Study Arms (2)

vinflunine and gemcitabine

EXPERIMENTAL

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

Drug: Vinflunine; Drug: Gemcitabine

placebo and gemcitabine

PLACEBO COMPARATOR

solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration

Drug: Gemcitabine; Other: Placebo

Interventions

Vinflunine DRUG

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

vinflunine and gemcitabine

Gemcitabine DRUG

solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration

placebo and gemcitabine; vinflunine and gemcitabine

Placebo OTHER

placebo and gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (112)

University Of Alabama At Birmingham

Birmingham, Alabama, 35294, United States

Location

Acrc/Arizona Clinical Research Center, Inc.

Tucson, Arizona, 85715, United States

Location

Tower Hematology Oncology Medical Group

Beverly Hills, California, 90211, United States

Location

Local Institution

Concord, California, 94520, United States

Location

Glendale Memorial Hospital And Health Center

Glendale, California, 91204, United States

Location

Moores Ucsd Cancer Center

La Jolla, California, 92093, United States

Location

North Valley Hematology/Oncology Medical Group

Mission Hills, California, 91345, United States

Location

Local Institution

Orange, California, 92868, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Local Institution

Newark, Delaware, 19718, United States

Location

University Of Florida College Of Medicine At Jacksonville

Jacksonville, Florida, 32209, United States

Location

Local Institution

Jacksonville, Florida, 32224, United States

Location

Lakeland Regional Cancer Center

Lakeland, Florida, 33805, United States

Location

University Of Miami

Miami, Florida, 33136, United States

Location

Advanced Medical Specialties

Miami, Florida, 33176, United States

Location

Medical College Of Georgia

Augusta, Georgia, 30912, United States

Location

Central Georgia Cancer Care, Pc

Macon, Georgia, 31201, United States

Location

University Of Chicago

Chicago, Illinois, 60637, United States

Location

Springfield Clinic, Llp

Springfield, Illinois, 62703, United States

Location

Michiana Hematology Oncology, P.C.

South Bend, Indiana, 46601, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mitchell Folbe, Md, Pc

Troy, Michigan, 48085, United States

Location

Local Institution

Minneapolis, Minnesota, 55455, United States

Location

Local Institution

Rochester, Minnesota, 55905, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

University Of Missouri Healthcare/Ellis Fischel Cancer Ctr

Columbia, Missouri, 65203, United States

Location

Capital Comprehensive Cancer Care Center

Jefferson City, Missouri, 65109, United States

Location

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, 64128, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Hematology Oncology Centers Of The Northern Rockies, Pc

Billings, Montana, 59101, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Nevada Cancer Centers

Las Vegas, Nevada, 89169, United States

Location

The Cancer Center At Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

The Mary Imogene Bassett Hospital

Cooperstown, New York, 13326, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

New York Presbyterian Hospital

New York, New York, 10065, United States

Location

University Of Rochester

Rochester, New York, 14642, United States

Location

Albert Einstein Cancer Center

The Bronx, New York, 10461, United States

Location

Carolinas Hematology Oncology Associates

Charlotte, North Carolina, 28203, United States

Location

Mid Dakota Clinic, Pc

Bismarck, North Dakota, 58501, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Mid-Ohio Oncology/Hematology, Inc. Dba

Columbus, Ohio, 43219, United States

Location

Abramson Cancer Center Of The

Philadelphia, Pennsylvania, 19104, United States

Location

Guthrie Foundation For Education And Research

Sayre, Pennsylvania, 18840, United States

Location

Charleston Cancer Center

Charleston, South Carolina, 29406, United States

Location

Medical University Of South Carolina

Charleston, South Carolina, 29425, United States

Location

The Jones Clinic, Pc

Germantown, Tennessee, 38138, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

The Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Lone Star Oncology Consulants, Pa

Austin, Texas, 78759, United States

Location

Cancer Specialists Of South Texas, Pa

Corpus Christi, Texas, 78412, United States

Location

The Center For Cancer And Blood Disorders

Fort Worth, Texas, 76104, United States

Location

University Of Texas Medical Branch Of Galveston

Galveston, Texas, 77555, United States

Location

South Texas Oncology And Hematology, P.A.

San Antonio, Texas, 78207, United States

Location

Northern Utah Associates

Ogden, Utah, 84403, United States

Location

Cancer Outreach Associates, Pc

Abingdon, Virginia, 24211, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr

Seattle, Washington, 98195, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Local Institution

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution

Tweed Heads, New South Wales, 2485, Australia

Location

Local Institution

Adelaide, South Australia, 5000, Australia

Location

Local Institution

Antwerp, Antwerp, 2020, Belgium

Location

Local Institution

Edegem, 2650, Belgium

Location

Local Institution

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Local Institution

Sydney, Nova Scotia, B1P 1P3, Canada

Location

Local Institution

London, Ontario, N6A 4L6, Canada

Location

Local Institution

Montreal, Quebec, H2L4MI, Canada

Location

Local Institution

Aarhus, 8000, Denmark

Location

Local Institution

Herlev, 2730, Denmark

Location

Local Institution

København Ø, 2100, Denmark

Location

Local Institution

Odense C, 5000, Denmark

Location

Local Institution

Caen, 14076, France

Location

Local Institution

Paris, 75679, France

Location

Local Institution

Vandœuvre-lès-Nancy, 54511, France

Location

Local Institution

Athens, 11528, Greece

Location

Local Institution

Jakarta, 11420, Indonesia

Location

Local Institution

Milan, 20141, Italy

Location

Local Institution

Trento, 38100, Italy

Location

Local Institution

Viterbo, 01100, Italy

Location

Local Institution

Cebu, 6000, Philippines

Location

Local Institution

Davao City, 8000, Philippines

Location

Local Institution

Manila, 1000, Philippines

Location

Local Institution

Quezon City, 1102, Philippines

Location

Local Institution

Bialystok, 15-276, Poland

Location

Local Institution

Gdansk, 80-402, Poland

Location

Local Institution

Krakow, 31-115, Poland

Location

Local Institution

Olsztyn, 10-228, Poland

Location

Local Institution

Poznan, 61-878-, Poland

Location

Local Institution

Warsaw, 02-781, Poland

Location

Local Institution

Obninsk, Kaluga Oblast, 249036, Russia

Location

Local Institution

Moscow, 125284, Russia

Location

Local Institution

Saint Petersburg, 195067, Russia

Location

Local Institution

Saint Petersburg, 198255, Russia

Location

Local Institution

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Local Institution

Seoul, 110-744, South Korea

Location

Local Institution

Seoul, 136-705, South Korea

Location

Local Institution

Barcelona, 08025, Spain

Location

Local Institution

Barcelona, 08035, Spain

Location

Local Institution

Murcia, 30008, Spain

Location

Local Institution

Palma de Mallorca, 07198, Spain

Location

Local Institution

Sabadell (Barcelona), 08208, Spain

Location

Local Institution

Santander, 39008, Spain

Location

Local Institution

Bangkok, 10330, Thailand

Location

Local Institution

Cardiff, Glamorgan, CF14 2TL, United Kingdom

Location

Local Institution

Grimsby, Lincolnshire, DN332BA, United Kingdom

Location

Local Institution

Nottingham, Nottinghamshire, NG51PB, United Kingdom

Location

Local Institution

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Neoplasm Metastasis

Interventions

vinflunine; Gemcitabine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2006
• First Posted: October 18, 2006
• Study Start: January 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: December 7, 2015

Record last verified: 2015-11

Locations

TH (1); RU (4); GB (4); US (64); PL (6); CA (4); ID (1); ES (6); GR (1); BE (2); FR (3); IT (3); DK (4); AU (2); KR (3); PH (4)