First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00389155
First received: October 17, 2006
Last updated: December 22, 2010
Last verified: December 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Transitional Cell Carcinoma Metastasis |
Drug: vinflunine and gemcitabine Drug: placebo and gemcitabine |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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 [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Tumor Response Rate in Participants With A Best Response of Complete (CR) or Partial (PR) as Defined by RECIST criteria [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]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.
- Overall Survival of Participants With TCC of the Urothelium [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]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.
- Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD) [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]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.
- Duration of Response in Participants With Best Response of CR or PR [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]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.
- Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation [ Designated as safety issue: Yes ]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.
- Number of Participants With Serum Chemistry Abnormalities by Worst Common Terminology Criteria (CTC) Grade [ Time Frame: Following Day 1 to no longer than 30 days after last dose of study medication ] [ Designated as safety issue: Yes ]
- Number of Participants With Abnormal Laboratory Findings by Worst CTC Grade [ Time Frame: Following Day 1 to no longer than 30 days after last dose of study medication ] [ Designated as safety issue: Yes ]
- Time to Response in Participants With Best Response of CR or PR [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]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.
| Enrollment: | 34 |
| Study Start Date: | January 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: vinflunine and gemcitabine
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
|
| Placebo Comparator: 2 |
Drug: placebo and gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389155
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| United States, Alabama | |
| University Of Alabama At Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Acrc/Arizona Clinical Research Center, Inc. | |
| Tucson, Arizona, United States, 85715 | |
| United States, California | |
| Tower Hematology Oncology Medical Group | |
| Beverly Hills, California, United States, 90211 | |
| Local Institution | |
| Concord, California, United States, 94520 | |
| Glendale Memorial Hospital And Health Center | |
| Glendale, California, United States, 91204 | |
| Moores Ucsd Cancer Center | |
| La Jolla, California, United States, 92093 | |
| North Valley Hematology/Oncology Medical Group | |
| Mission Hills, California, United States, 91345 | |
| Local Institution | |
| Orange, California, United States, 92868 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Delaware | |
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| Newark, Delaware, United States, 19718 | |
| United States, Florida | |
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| Jacksonville, Florida, United States, 32224 | |
| University Of Florida College Of Medicine At Jacksonville | |
| Jacksonville, Florida, United States, 32209 | |
| Lakeland Regional Cancer Center | |
| Lakeland, Florida, United States, 33805 | |
| Advanced Medical Specialties | |
| Miami, Florida, United States, 33176 | |
| University Of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Medical College Of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| Central Georgia Cancer Care, Pc | |
| Macon, Georgia, United States, 31201 | |
| United States, Illinois | |
| University Of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Springfield Clinic, Llp | |
| Springfield, Illinois, United States, 62703 | |
| United States, Indiana | |
| Michiana Hematology Oncology, P.C. | |
| South Bend, Indiana, United States, 46601 | |
| United States, Kentucky | |
| James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Mitchell Folbe, Md, Pc | |
| Troy, Michigan, United States, 48085 | |
| United States, Minnesota | |
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| Minneapolis, Minnesota, United States, 55455 | |
| Local Institution | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Missouri Cancer Associates | |
| Columbia, Missouri, United States, 65201 | |
| University Of Missouri Healthcare/Ellis Fischel Cancer Ctr | |
| Columbia, Missouri, United States, 65203 | |
| Capital Comprehensive Cancer Care Center | |
| Jefferson City, Missouri, United States, 65109 | |
| Kansas City Veterans Affairs Medical Center | |
| Kansas City, Missouri, United States, 64128 | |
| Washington University School Of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| Hematology Oncology Centers Of The Northern Rockies, Pc | |
| Billings, Montana, United States, 59101 | |
| Billings Clinic | |
| Billings, Montana, United States, 59101 | |
| United States, Nevada | |
| Nevada Cancer Institute | |
| Las Vegas, Nevada, United States, 89135 | |
| Nevada Cancer Centers | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, New Jersey | |
| The Cancer Center At Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Albert Einstein Cancer Center | |
| Bronx, New York, United States, 10461 | |
| The Mary Imogene Bassett Hospital | |
| Cooperstown, New York, United States, 13326 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| New York Presbyterian Hospital | |
| New York, New York, United States, 10065 | |
| University Of Rochester | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Carolinas Hematology Oncology Associates | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, North Dakota | |
| Mid Dakota Clinic, Pc | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| Mid-Ohio Oncology/Hematology, Inc. Dba | |
| Columbus, Ohio, United States, 43219 | |
| United States, Pennsylvania | |
| Abramson Cancer Center Of The | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Guthrie Foundation For Education And Research | |
| Sayre, Pennsylvania, United States, 18840 | |
| United States, South Carolina | |
| Medical University Of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Charleston Cancer Center | |
| Charleston, South Carolina, United States, 29406 | |
| United States, Tennessee | |
| The Jones Clinic, Pc | |
| Germantown, Tennessee, United States, 38138 | |
| The West Clinic | |
| Memphis, Tennessee, United States, 38120 | |
| The Sarah Cannon Research Institute | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Lone Star Oncology Consulants, Pa | |
| Austin, Texas, United States, 78759 | |
| Cancer Specialists Of South Texas, Pa | |
| Corpus Christi, Texas, United States, 78412 | |
| The Center For Cancer And Blood Disorders | |
| Fort Worth, Texas, United States, 76104 | |
| University Of Texas Medical Branch Of Galveston | |
| Galveston, Texas, United States, 77555 | |
| South Texas Oncology And Hematology, P.A. | |
| San Antonio, Texas, United States, 78207 | |
| United States, Utah | |
| Northern Utah Associates | |
| Ogden, Utah, United States, 84403 | |
| United States, Virginia | |
| Cancer Outreach Associates, Pc | |
| Abingdon, Virginia, United States, 24211 | |
| Virginia Oncology Associates | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
| Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr | |
| Seattle, Washington, United States, 98195 | |
| United States, West Virginia | |
| West Virginia University | |
| Morgantown, West Virginia, United States, 26506 | |
| United States, Wisconsin | |
| Local Institution | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Australia, New South Wales | |
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| Tweed Heads, New South Wales, Australia, 2485 | |
| Australia, South Australia | |
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| Adelaide, South Australia, Australia, 5000 | |
| Belgium | |
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| Antwerp, Belgium, 2020 | |
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| Edegem, Belgium, 2650 | |
| Canada, New Brunswick | |
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| Moncton, New Brunswick, Canada, E1C 6Z8 | |
| Canada, Nova Scotia | |
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| Sydney, Nova Scotia, Canada, B1P 1P3 | |
| Canada, Ontario | |
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| London, Ontario, Canada, N6A 4L6 | |
| Canada, Quebec | |
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| Montreal, Quebec, Canada, H2L4MI | |
| Denmark | |
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| Arhus, Denmark, 8000 | |
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| Herlev, Denmark, 2730 | |
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| Kobenhavn O, Denmark, 2100 | |
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| Odense C, Denmark, 5000 | |
| France | |
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| Caen Cedex 05, France, 14076 | |
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| Paris Cedex 14, France, 75679 | |
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| Vandoeuvre Les Nancy, France, 54511 | |
| Greece | |
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| Athens, Greece, 11528 | |
| Indonesia | |
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| Jakarta, Indonesia, 11420 | |
| Italy | |
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| Milan, Italy, 20141 | |
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| Trento, Italy, 38100 | |
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| Viterbo, Italy, 01100 | |
| Korea, Republic of | |
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| Seongnam, Gyeonggi-Do, Korea, Republic of, 463-707 | |
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| Seoul, Korea, Republic of, 136-705 | |
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| Seoul, Korea, Republic of, 110-744 | |
| Philippines | |
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| Cebu, Philippines, 6000 | |
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| Davao City, Philippines, 8000 | |
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| Manila, Philippines, 1000 | |
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| Quezon City, Philippines, 1102 | |
| Poland | |
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| Bialystok, Poland, 15-276 | |
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| Cracow, Poland, 31-115 | |
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| Gdansk, Poland, 80-402 | |
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| Olsztyn, Poland, 10-228 | |
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| Poznan, Poland, 61-878- | |
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| Warsaw, Poland, 02-781 | |
| Russian Federation | |
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| Obninsk, Kaluga Region, Russian Federation, 249036 | |
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| Moscow, Russian Federation, 125284 | |
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| Saint Petersburg, Russian Federation, 195067 | |
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| St Petersburg, Russian Federation, 198255 | |
| Spain | |
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| Barcelona, Spain, 08035 | |
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| Barcelona, Spain, 08025 | |
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| Murcia, Spain, 30008 | |
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| Palma De Mallorca, Spain, 07198 | |
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| Sabadell (Barcelona), Spain, 08208 | |
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| Santander, Spain, 39008 | |
| Thailand | |
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| Bangkok, Thailand, 10330 | |
| United Kingdom | |
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| Cardiff, Glamorgan, United Kingdom, CF14 2TL | |
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| Grimsby, Lincolnshire, United Kingdom, DN332BA | |
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| Nottingham, Nottinghamshire, United Kingdom, NG51PB | |
| Local Institution | |
| Birmingham, West Midlands, United Kingdom, B15 2TT | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00389155 History of Changes |
| Other Study ID Numbers: | CA183-002 |
| Study First Received: | October 17, 2006 |
| Last Updated: | December 22, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Advanced or metastatic transitional cell carcinoma of the urothelium |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Carcinoma Carcinoma, Transitional Cell Neoplasm Metastasis Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Gemcitabine |
Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 22, 2013