Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00101608

Collaborator

Pierre Fabre Medicament (Industry)

150

Enrollment

Locations

Arm

26.9

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical research study is to learn if vinflunine can shrink or slow the growth of the cancer or increase survival in patients with transitional cell carcinoma of the urothelium. The safety of this treatment will also be studied.

Condition or Disease	Intervention/Treatment	Phase
Transitional Cell Carcinoma Bladder Neoplasms Kidney Neoplasms Ureter Neoplasms Bladder Cancer Neoplasm, Bladder	Drug: vinflunine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: vinflunine solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration

Arm

Intervention/Treatment

Experimental: 1

Drug: vinflunine

solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration

Outcome Measures

Primary Outcome Measures

To estimate the objective response rate in patients with TCC of the urothelium receiving vinflunine, who had evidence of documented progression at any time within 12 months after the last dose of platinum therapy and are not candidates of cystectomy. [10-Apr-2007]

Secondary Outcome Measures

To estimate duration of response, time to response disease control rate, progression free survival, and overall survival in this patient population, and evaluate the safety profile of vinflunine [10-April-2007]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic (i.e. patients cannot be candidates for local/regional control of disease).
Relapse or progression within 12.5 months of prior cisplatin or carboplatin containing chemotherapy regimen.
Adequate performance status (Karnofsky greater or equal to 80).

Exclusion Criteria:

Receipt of more than 1 prior chemotherapy regimen in any setting.
Prior discontinuation of platinum due solely to toxicity.
Current neuropathy greater or equal to CTC grade 2.
Prior radiation to greater or equal to 30% of bone marrow.
Inadequate hematologic function: ANC <1,500 cells/mm3, Platelet<100,000 cells/mm3.
Inadequate hepatic function: total bilirubin > 1.5 times ULN, ALT/AST > 2.5 times ULN or > 5 times ULN in case of liver metastasis.
Inadequate renal function: creatinine clearance <20 ml/min.
Prior allergy to any vinca-alkaloid.

Contacts and Locations

Locations

	Site	City	State	Country
1	Local Institution	Beverly Hills	California	United States
2	Local Institution	La Jolla	California	United States
3	Local Institution	Los Angeles	California	United States
4	Local Institution	Santa Monica	California	United States
5	Local Institution	Stanford	California	United States
6	Local Institution	Vallejo	California	United States
7	Local Institution	Aurora	Colorado	United States
8	Local Institution	New Haven	Connecticut	United States
9	Local Institution	Washington	District of Columbia	United States
10	Local Institution	Jacksonville	Florida	United States
11	Local Institution	Miami	Florida	United States
12	Local Institution	Atlanta	Georgia	United States
13	Local Institution	Honolulu	Hawaii	United States
14	Local Institution	Chicago	Illinois	United States
15	Local Institution	Joliet	Illinois	United States
16	Local Institution	Urbana	Illinois	United States
17	Local Institution	Louisville	Kentucky	United States
18	Local Institution	Baltimore	Maryland	United States
19	Local Institution	Burlington	Massachusetts	United States
20	Local Institution	Ann Arbor	Michigan	United States
21	Local Institution	Detroit	Michigan	United States
22	Local Institution	Kansas City	Missouri	United States
23	Local Institution	St. Louis	Missouri	United States
24	Local Institution	Las Vegas	Nevada	United States
25	Local Institution	Lebanon	New Hampshire	United States
26	Local Institution	Bronx	New York	United States
27	Local Institution	Buffalo	New York	United States
28	Local Institution	New York	New York	United States
29	Local Institution	Charlotte	North Carolina	United States
30	Local Institution	Durham	North Carolina	United States
31	Local Institution	Cincinnati	Ohio	United States
32	Local Institution	Philadelphia	Pennsylvania	United States
33	Local Institution	Pittsburgh	Pennsylvania	United States
34	Local Institution	Providence	Rhode Island	United States
35	Local Institution	Nashville	Tennessee	United States
36	Local Institution	Dallas	Texas	United States
37	Local Institution	Seattle	Washington	United States
38	Local Institution	Milwaukee	Wisconsin	United States
39	Local Institution	Liverpool	New South Wales	Australia
40	Local Institution	Sydney	New South Wales	Australia
41	Local Institution	Taree	New South Wales	Australia
42	Local Institution	Waratah	New South Wales	Australia
43	Local Institution	Westmead	New South Wales	Australia
44	Local Institution	Adelaide	South Australia	Australia
45	Local Institution	Linz		Austria
46	Local Institution	Salzburg		Austria
47	Local Institution	Edmonton	Alberta	Canada
48	Local Institution	London	Ontario	Canada
49	Local Insitution	Toronto	Ontario	Canada
50	Local Institution	Montreal	Quebec	Canada
51	Local Institution	Caen		France
52	Local Institution	Le Mans Cedex 2		France
53	Local Institution	Nice		France
54	Local Institution	Paris		France
55	Local Institution	Toulouse		France
56	Local Institution	Ilion		Greece
57	Local Institution	Jakarta		Indonesia
58	Local Institution	Genova		Italy
59	Local Institution	Milan		Italy
60	Local Institution	Roma		Italy
61	Local Institution	Rome		Italy
62	Local Institution	Viterbo		Italy
63	Local Institution	Seoul		Korea, Republic of
64	Local Institution	Cebu City		Philippines
65	Local Institution	Quezon City		Philippines
66	Local Institution	Quezon		Philippines
67	Local Institution	Singapore		Singapore
68	Local Institution	Murcia		Spain
69	Local Institution	Palma De Mallorca		Spain
70	Local Institution	Santander		Spain
71	Local Institution	Sevilla		Spain
72	Local Institution	Linkoping		Sweden
73	Local Institution	Uppsala		Sweden
74	Local Institution	Aarau		Switzerland
75	Local Institution	Bangkok		Thailand