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Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial Cancer

NCT01529411 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2019-04-04

No results posted yet for this study

Summary

This is a clinical trial to evaluate the efficacy and safety of the drug vinflunine administered after the standard treatment of the combination gemcitabine+cisplatin, when it has reached stabilization or response of the disease, as the first treatment inmeditely after the diagnosis of advanced or metastatic urothelial cancer.

Conditions

  • Carcinoma, Transitional Cell

Interventions

DRUG

Vinflunine

Vinflunine 320 mg/m2 IV infusion in 20 minutes every 21 days (280mg/m2 if PS=1, age ≥ 75 years, previous pelvic radiotherapy or creatinine clearance \< 60ml/min).

OTHER

Undefined (standard care)

All the current interventions used by each institution for the study disease.

Sponsors & Collaborators

  • Spanish Oncology Genito-Urinary Group

    lead OTHER

Principal Investigators

  • Jesús García-Donas, MD · Hospital Universitario Fundación Alcorcón

  • Albert Font, MD · ICO-Hospital Universitari Germans Trias i Pujol

  • Joaquim Bellmunt, MD · H. del Mar - FIMIM (Fundació Institut Mar d´Investigacions Mèdiques)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-02-28
Completion
2014-12-31

Countries

  • 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 NCT01529411 on ClinicalTrials.gov