Bladder CancerPhase 2/3NCT00389155
First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
A Phase 2/3 study testing Vinflunine and Gemcitabine in people with Bladder Cancer and Transitional Cell Carcinoma, run by Bristol-Myers Squibb at 112 sites in 16 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Transitional Cell Carcinoma, Metastasis
- What is being tested?
- Vinflunine and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 112 sitesin 16 countries
- Study dates
- Jan 2007to Jan 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
112 sites in 16 countries.
112 sites in 16 countries
United States64 sites
Cancer Outreach Associates, Pc
Abingdon, Virginia, 24211
Medical College Of Georgia
Augusta, Georgia, 30912
Lone Star Oncology Consulants, Pa
Austin, Texas, 78759
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21231
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211
Billings Clinic
Billings, Montana, 59101
Hematology Oncology Centers Of The Northern Rockies, Pc
Billings, Montana, 59101
University Of Alabama At Birmingham
Birmingham, Alabama, 35294
Mid Dakota Clinic, Pc
Bismarck, North Dakota, 58501
Charleston Cancer Center
Charleston, South Carolina, 29406
Medical University Of South Carolina
Charleston, South Carolina, 29425
Carolinas Hematology Oncology Associates
Charlotte, North Carolina, 28203
University Of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Missouri Cancer Associates
Columbia, Missouri, 65201
University Of Missouri Healthcare/Ellis Fischel Cancer Ctr
Columbia, Missouri, 65203
Mid-Ohio Oncology/Hematology, Inc. Dba
Columbus, Ohio, 43219
Local Institution
Concord, California, 94520
The Mary Imogene Bassett Hospital
Cooperstown, New York, 13326
Cancer Specialists Of South Texas, Pa
Corpus Christi, Texas, 78412
Henry Ford Hospital
Detroit, Michigan, 48202
The Center For Cancer And Blood Disorders
Fort Worth, Texas, 76104
University Of Texas Medical Branch Of Galveston
Galveston, Texas, 77555
The Jones Clinic, Pc
Germantown, Tennessee, 38138
Glendale Memorial Hospital And Health Center
Glendale, California, 91204
The Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, 07601
University Of Florida College Of Medicine At Jacksonville
Jacksonville, Florida, 32209
Local Institution
Jacksonville, Florida, 32224
Capital Comprehensive Cancer Care Center
Jefferson City, Missouri, 65109
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128
Moores Ucsd Cancer Center
La Jolla, California, 92093
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Nevada Cancer Institute
Las Vegas, Nevada, 89135
Nevada Cancer Centers
Las Vegas, Nevada, 89169
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Central Georgia Cancer Care, Pc
Macon, Georgia, 31201
The West Clinic
Memphis, Tennessee, 38120
University Of Miami
Miami, Florida, 33136
Advanced Medical Specialties
Miami, Florida, 33176
Local Institution
Milwaukee, Wisconsin, 53226
Local Institution
Minneapolis, Minnesota, 55455
North Valley Hematology/Oncology Medical Group
Mission Hills, California, 91345
West Virginia University
Morgantown, West Virginia, 26506
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Columbia University Medical Center
New York, New York, 10032
New York Presbyterian Hospital
New York, New York, 10065
Local Institution
Newark, Delaware, 19718
Virginia Oncology Associates
Norfolk, Virginia, 23502
Northern Utah Associates
Ogden, Utah, 84403
Local Institution
Orange, California, 92868
Abramson Cancer Center Of The
Philadelphia, Pennsylvania, 19104
Local Institution
Rochester, Minnesota, 55905
University Of Rochester
Rochester, New York, 14642
South Texas Oncology And Hematology, P.A.
San Antonio, Texas, 78207
Guthrie Foundation For Education And Research
Sayre, Pennsylvania, 18840
Virginia Mason Medical Center
Seattle, Washington, 98101
Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr
Seattle, Washington, 98195
Michiana Hematology Oncology, P.C.
South Bend, Indiana, 46601
Springfield Clinic, Llp
Springfield, Illinois, 62703
Washington University School Of Medicine
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
Albert Einstein Cancer Center
The Bronx, New York, 10461
Mitchell Folbe, Md, Pc
Troy, Michigan, 48085
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85715
Poland6 sites
Local Institution
Bialystok, 15-276
Local Institution
Cracow, 31-115
Local Institution
Gdansk, 80-402
Local Institution
Olsztyn, 10-228
Local Institution
Poznan, 61-878-
Local Institution
Warsaw, 02-781
Spain6 sites
Local Institution
Barcelona, 08025
Local Institution
Barcelona, 08035
Local Institution
Murcia, 30008
Local Institution
Palma de Mallorca, 07198
Local Institution
Sabadell (Barcelona), 08208
Local Institution
Santander, 39008
Canada4 sites
Local Institution
London, Ontario, N6A 4L6
Local Institution
Moncton, New Brunswick, E1C 6Z8
Local Institution
Montreal, Quebec, H2L4MI
Local Institution
Sydney, Nova Scotia, B1P 1P3
Denmark4 sites
Local Institution
Aarhus, 8000
Local Institution
Herlev, 2730
Local Institution
København Ø, 2100
Local Institution
Odense C, 5000
Philippines4 sites
Local Institution
Cebu, 6000
Local Institution
Davao City, 8000
Local Institution
Manila, 1000
Local Institution
Quezon City, 1102
Russia4 sites
Local Institution
Moscow, 125284
Local Institution
Obninsk, Kaluga Oblast, 249036
Local Institution
Saint Petersburg, 195067
Local Institution
Saint Petersburg, 198255
United Kingdom4 sites
Local Institution
Birmingham, West Midlands, B15 2TT
Local Institution
Cardiff, Glamorgan, CF14 2TL
Local Institution
Grimsby, Lincolnshire, DN332BA
Local Institution
Nottingham, Nottinghamshire, NG51PB
France3 sites
Local Institution
Caen, 14076
Local Institution
Paris, 75679
Local Institution
Vandœuvre-lès-Nancy, 54511
Italy3 sites
Local Institution
Milan, 20141
Local Institution
Trento, 38100
Local Institution
Viterbo, 01100
South Korea3 sites
Local Institution
Seongnam-si, Gyeonggi-do, 463-707
Local Institution
Seoul, 110-744
Local Institution
Seoul, 136-705
Australia2 sites
Local Institution
Adelaide, South Australia, 5000
Local Institution
Tweed Heads, New South Wales, 2485
Belgium2 sites
Local Institution
Antwerp, Antwerp, 2020
Local Institution
Edegem, 2650
About this study
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
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
- Being tested
- Vinflunine, Gemcitabine, Placebo
- Keywords
- Advanced or metastatic transitional cell carcinoma of the urothelium
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinflunineDrug
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
GemcitabineDrug
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| vinflunine and gemcitabine | Experimental | solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration Receives: Drug: Vinflunine; Drug: Gemcitabine |
| placebo and gemcitabine | Placebo comparator | solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration Receives: Drug: Gemcitabine; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Number of Participants With Serum Chemistry Abnormalities by Worst Common Terminology Criteria (CTC) Grade
Measured: Following Day 1 to no longer than 30 days after last dose of study medication
Number of Participants With Abnormal Laboratory Findings by Worst CTC Grade
Measured: Following Day 1 to no longer than 30 days after last dose of study medication
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.
Measured: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2006 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389155
- Sponsor's protocol ID
- CA183-002
- Status last verified
- Nov 2015
- First submitted
- 17 Oct 2006
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00389155
- Acronym / sponsor ID
- CA183-002
- Conditions
- Bladder Cancer, Transitional Cell Carcinoma, Metastasis
- Keywords
- Advanced or metastatic transitional cell carcinoma of the urothelium
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 18 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vinflunine and gemcitabine | Experimental | Drug: Vinflunine, Drug: Gemcitabinesolution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration |
| placebo and gemcitabine | Placebo comparator | Drug: Gemcitabine, Other: Placebosolution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vinfluninesolution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration | Drug | vinflunine and gemcitabine |
| Gemcitabinesolution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration | Drug | placebo and gemcitabine, vinflunine and gemcitabine |
| Placebo | Other | placebo and gemcitabine |
Primary outcome
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
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.
8 secondary outcomes
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
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
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
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
Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation
Time frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
112 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vinflunine and Gemcitabine in people with Bladder Cancer and Transitional Cell Carcinoma, run by Bristol-Myers Squibb at 112 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 112 sites in United States, Poland, Spain, Canada, Denmark and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.