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NCT Number: NCT00315237

Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract

The purpose of this clinical research study is to learn if patients who receive vinflunine plus best supportive care live longer than patients who receive best supportive care alone. This study will also investigate patient benefit, safety and whether or not vinflunine shrinks or slows the growth of the cancer.

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Key information

Conditions

Transitional Cell Carcinoma of the Urothelial Tract Bladder Cancer Bladder Neoplasms Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bladder cancer
  • Progressed after 1st line platinum-chemotherapy
  • >= 18 years old
  • Adequate hematologic, hepatic & renal function

Exclusion criteria

  • CNS disease
  • Moderate neuropathy
  • More than 1 previous chemotherapy

Treatment and study plan

vinflunine and best supportive care

Drug

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

Primary outcomes

  1. duration of Overall Survival after Randomization

    Time frame: 30-March-07

Secondary outcomes

  1. patient benefit

    Time frame: 30-Mar-07

  2. safety

    Time frame: 30-Mar-2007

  3. response rate

    Time frame: throughout the study

  4. time to response

    Time frame: upon occurrence

  5. response duration

    Time frame: throughout the study

  6. progression free survival

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

Prospective, Randomized Phase III Trial of I.V. Vinflunine Plus Best Supportive Care as Second Line Therapy Versus Best Supportive Care After a Platinum-containing Regimen, in Patients With Advanced Transitional Cell Carcinoma of Urothelial Tract

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Apr 18, 2006
Registry last updated
Jan 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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