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NCT Number: NCT00101608

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

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.

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Key information

Conditions

Transitional Cell Carcinoma Bladder Cancer Bladder Neoplasms Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasm, Bladder Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ureter Neoplasms Ureteral Diseases Ureteral Neoplasms 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 2

Primary location

Local Institution, Liverpool, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Vinflunine

Drug

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

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.

    Time frame: 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

    Time frame: 10-April-2007

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Pierre Fabre Medicament

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 13, 2005
Registry last updated
Mar 2, 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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