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

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ClinicalTrials.gov Identifier: NCT00101608
Recruitment Status : Completed
First Posted : January 13, 2005
Last Update Posted : March 2, 2010
Sponsor:
Collaborator:
Pierre Fabre Medicament
Information provided by:
Bristol-Myers Squibb

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

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


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 10-Apr-2007 ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 10-April-2007 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101608


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Pierre Fabre Medicament
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00101608    
Obsolete Identifiers: NCT00268424
Other Study ID Numbers: CA183-001
First Posted: January 13, 2005    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: August 2008
Keywords provided by Bristol-Myers Squibb:
urothelium
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Kidney Diseases
Ureteral Diseases