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

NCT00101608 | Completed Phase 2

• 1 other identifier: CA183-001
• Study Type: interventional
• Target: 150
• Locations: 14 countries
• Sites: 69

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.

Conditions

Transitional Cell Carcinoma; Bladder Neoplasms; Kidney Neoplasms; Ureter Neoplasms; Bladder Cancer; Neoplasm, Bladder

Keywords

urothelium

Outcome Measures

Primary Outcomes (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.

  10-Apr-2007

Secondary Outcomes (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

  10-April-2007

Study Arms (1)

1

EXPERIMENTAL

Drug: vinflunine

Interventions

vinflunine DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Pierre Fabre Medicament: collaborator

Study Sites (75)

Local Institution

Beverly Hills, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Santa Monica, California, United States

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Stanford, California, United States

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Vallejo, California, United States

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Aurora, Colorado, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Joliet, Illinois, United States

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Urbana, Illinois, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Burlington, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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Buffalo, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Seattle, Washington, United States

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Milwaukee, Wisconsin, United States

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Liverpool, New South Wales, Australia

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Sydney, New South Wales, Australia

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Taree, New South Wales, Australia

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Waratah, New South Wales, Australia

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Westmead, New South Wales, Australia

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Adelaide, South Australia, Australia

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Linz, Austria

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Salzburg, Austria

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Edmonton, Alberta, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Caen, France

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Le Mans, France

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Nice, France

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Paris, France

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Toulouse, France

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Nea Liosia, Greece

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Jakarta, Indonesia

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Genova, Italy

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Milan, Italy

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Roma, Italy

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Rome, Italy

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Viterbo, Italy

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Cebu City, Philippines

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Quezon, Philippines

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Quezon City, Philippines

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Singapore, Singapore

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Seoul, South Korea

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Murcia, Spain

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Palma de Mallorca, Spain

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Santander, Spain

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Seville, Spain

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Linköping, Sweden

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Uppsala, Sweden

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Aarau, Switzerland

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Bangkok, Thailand

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MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms; Kidney Neoplasms; Ureteral Neoplasms

Interventions

vinflunine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Kidney Diseases; Ureteral Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 12, 2005
• First Posted: January 13, 2005
• Study Start: January 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: March 2, 2010

Record last verified: 2008-08

Locations

ID (1); PH (3); CA (4); SG (1); AU (2); ES (4); CH (1); TH (1); US (38); GR (1); IT (5); KR (1); SE (2); FR (5)