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Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU)

NCT01830231 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2014-01-28

No results posted yet for this study

Summary

Due to limited experience with cabazitaxel in TCCU, the study will be started as a randomised phase II study. The aim of the phase II study is to evaluate if the response rates (CR + PR) are sufficiently high to further study the treatment regimens in a phase III setting.

Conditions

  • Urothelium Transitional Cell Carcinoma

Interventions

DRUG

Cabazitaxel

Cabazitaxel, to be given intravenously once every 21 days, starting at a dose of 25 mg/m2 as a 1-hour intravenous infusion.

DRUG

Vinflunine

Vinflunine, to be given intravenously once every 21 days, as a 20 minute intravenous infusion, starting at a dose of: * 320 mg/m2 in patients aged ≤75 years with PS 0 and no prior pelvic radiation, and of * 280 mg/m2 in patients aged \>75 - ≤80 years or with PS 1 or prior pelvic radiation, * 250 mg/m2 in patients aged \>80 years.

Sponsors & Collaborators

  • Associació per a la Recerca Oncologica, Spain

    lead OTHER

Principal Investigators

  • Joaquim Bellmunt, MD/PhD · APRO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Netherlands
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01830231 on ClinicalTrials.gov