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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00389155
Collaborator
(none)
34
Enrollment
112
Locations
2
Arms
12
Duration (Months)
0.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: vinflunine and gemcitabine

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

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

Drug: Gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
Placebo Comparator: placebo and gemcitabine

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

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

Other: Placebo

Outcome Measures

Primary Outcome Measures

  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 [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.

Secondary Outcome Measures

  1. 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]

    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.

  2. Overall Survival of Participants With TCC of the Urothelium [Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision]

    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.

  3. 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]

    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.

  4. 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]

    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.

  5. 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]

    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.

  6. 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]

  7. 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]

  8. Time to Response in Participants With Best Response of CR or PR [Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University Of Alabama At Birmingham Birmingham Alabama United States 35294
2 Acrc/Arizona Clinical Research Center, Inc. Tucson Arizona United States 85715
3 Tower Hematology Oncology Medical Group Beverly Hills California United States 90211
4 Local Institution Concord California United States 94520
5 Glendale Memorial Hospital And Health Center Glendale California United States 91204
6 Moores Ucsd Cancer Center La Jolla California United States 92093
7 North Valley Hematology/Oncology Medical Group Mission Hills California United States 91345
8 Local Institution Orange California United States 92868
9 Stanford University Stanford California United States 94305
10 Local Institution Newark Delaware United States 19718
11 University Of Florida College Of Medicine At Jacksonville Jacksonville Florida United States 32209
12 Local Institution Jacksonville Florida United States 32224
13 Lakeland Regional Cancer Center Lakeland Florida United States 33805
14 University Of Miami Miami Florida United States 33136
15 Advanced Medical Specialties Miami Florida United States 33176
16 Medical College Of Georgia Augusta Georgia United States 30912
17 Central Georgia Cancer Care, Pc Macon Georgia United States 31201
18 University Of Chicago Chicago Illinois United States 60637
19 Springfield Clinic, Llp Springfield Illinois United States 62703
20 Michiana Hematology Oncology, P.C. South Bend Indiana United States 46601
21 James Graham Brown Cancer Center Louisville Kentucky United States 40202
22 Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Baltimore Maryland United States 21231
23 Henry Ford Hospital Detroit Michigan United States 48202
24 Mitchell Folbe, Md, Pc Troy Michigan United States 48085
25 Local Institution Minneapolis Minnesota United States 55455
26 Local Institution Rochester Minnesota United States 55905
27 Missouri Cancer Associates Columbia Missouri United States 65201
28 University Of Missouri Healthcare/Ellis Fischel Cancer Ctr Columbia Missouri United States 65203
29 Capital Comprehensive Cancer Care Center Jefferson City Missouri United States 65109
30 Kansas City Veterans Affairs Medical Center Kansas City Missouri United States 64128
31 Washington University School Of Medicine St. Louis Missouri United States 63110
32 Billings Clinic Billings Montana United States 59101
33 Hematology Oncology Centers Of The Northern Rockies, Pc Billings Montana United States 59101
34 Nevada Cancer Institute Las Vegas Nevada United States 89135
35 Nevada Cancer Centers Las Vegas Nevada United States 89169
36 The Cancer Center At Hackensack University Medical Center Hackensack New Jersey United States 07601
37 Albert Einstein Cancer Center Bronx New York United States 10461
38 The Mary Imogene Bassett Hospital Cooperstown New York United States 13326
39 Columbia University Medical Center New York New York United States 10032
40 New York Presbyterian Hospital New York New York United States 10065
41 University Of Rochester Rochester New York United States 14642
42 Carolinas Hematology Oncology Associates Charlotte North Carolina United States 28203
43 Mid Dakota Clinic, Pc Bismarck North Dakota United States 58501
44 Cleveland Clinic Cleveland Ohio United States 44195
45 Mid-Ohio Oncology/Hematology, Inc. Dba Columbus Ohio United States 43219
46 Abramson Cancer Center Of The Philadelphia Pennsylvania United States 19104
47 Guthrie Foundation For Education And Research Sayre Pennsylvania United States 18840
48 Charleston Cancer Center Charleston South Carolina United States 29406
49 Medical University Of South Carolina Charleston South Carolina United States 29425
50 The Jones Clinic, Pc Germantown Tennessee United States 38138
51 The West Clinic Memphis Tennessee United States 38120
52 The Sarah Cannon Research Institute Nashville Tennessee United States 37203
53 Lone Star Oncology Consulants, Pa Austin Texas United States 78759
54 Cancer Specialists Of South Texas, Pa Corpus Christi Texas United States 78412
55 The Center For Cancer And Blood Disorders Fort Worth Texas United States 76104
56 University Of Texas Medical Branch Of Galveston Galveston Texas United States 77555
57 South Texas Oncology And Hematology, P.A. San Antonio Texas United States 78207
58 Northern Utah Associates Ogden Utah United States 84403
59 Cancer Outreach Associates, Pc Abingdon Virginia United States 24211
60 Virginia Oncology Associates Norfolk Virginia United States 23502
61 Virginia Mason Medical Center Seattle Washington United States 98101
62 Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr Seattle Washington United States 98195
63 West Virginia University Morgantown West Virginia United States 26506
64 Local Institution Milwaukee Wisconsin United States 53226
65 Local Institution Tweed Heads New South Wales Australia 2485
66 Local Institution Adelaide South Australia Australia 5000
67 Local Institution Antwerp Belgium 2020
68 Local Institution Edegem Belgium 2650
69 Local Institution Moncton New Brunswick Canada E1C 6Z8
70 Local Institution Sydney Nova Scotia Canada B1P 1P3
71 Local Institution London Ontario Canada N6A 4L6
72 Local Institution Montreal Quebec Canada H2L4MI
73 Local Institution Arhus Denmark 8000
74 Local Institution Herlev Denmark 2730
75 Local Institution Kobenhavn O Denmark 2100
76 Local Institution Odense C Denmark 5000
77 Local Institution Caen Cedex 05 France 14076
78 Local Institution Paris Cedex 14 France 75679
79 Local Institution Vandoeuvre Les Nancy France 54511
80 Local Institution Athens Greece 11528
81 Local Institution Jakarta Indonesia 11420
82 Local Institution Milan Italy 20141
83 Local Institution Trento Italy 38100
84 Local Institution Viterbo Italy 01100
85 Local Institution Seongnam Gyeonggi-Do Korea, Republic of 463-707
86 Local Institution Seoul Korea, Republic of 110-744
87 Local Institution Seoul Korea, Republic of 136-705
88 Local Institution Cebu Philippines 6000
89 Local Institution Davao City Philippines 8000
90 Local Institution Manila Philippines 1000
91 Local Institution Quezon City Philippines 1102
92 Local Institution Bialystok Poland 15-276
93 Local Institution Cracow Poland 31-115
94 Local Institution Gdansk Poland 80-402
95 Local Institution Olsztyn Poland 10-228
96 Local Institution Poznan Poland 61-878-
97 Local Institution Warsaw Poland 02-781
98 Local Institution Obninsk Kaluga Region Russian Federation 249036
99 Local Institution Moscow Russian Federation 125284
100 Local Institution Saint Petersburg Russian Federation 195067
101 Local Institution St Petersburg Russian Federation 198255
102 Local Institution Barcelona Spain 08025
103 Local Institution Barcelona Spain 08035
104 Local Institution Murcia Spain 30008
105 Local Institution Palma De Mallorca Spain 07198
106 Local Institution Sabadell (Barcelona) Spain 08208
107 Local Institution Santander Spain 39008
108 Local Institution Bangkok Thailand 10330
109 Local Institution Cardiff Glamorgan United Kingdom CF14 2TL
110 Local Institution Grimsby Lincolnshire United Kingdom DN332BA
111 Local Institution Nottingham Nottinghamshire United Kingdom NG51PB
112 Local Institution Birmingham West Midlands United Kingdom B15 2TT

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00389155
Other Study ID Numbers:
  • CA183-002
First Posted:
Oct 18, 2006
Last Update Posted:
Dec 7, 2015
Last Verified:
Nov 1, 2015
Keywords provided by Bristol-Myers Squibb
Advanced or metastatic transitional cell carcinoma of the urothelium
Additional relevant MeSH terms:
Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Gemcitabine

Study Results

No Results Posted as of Dec 7, 2015