Trial intelligence / Profile preview

Gene Expression Profiling for M-VAC in Invasive Bladder Cancer

NCT00516750Phase 2

Key facts

Status
Terminated
Start
Jul 2007
Primary completion
Feb 2009
Countries
1
Sponsor
Kyoto University
Modality
DNA Intercalators/Alkylators, Orthosteric Ligands
Conditions
bladder neoplasm
01

Overview

Phase 2, open-label, single-arm trial of cisplatin, doxorubicin, methotrexate and vinblastine in bladder neoplasm, sponsored by Kyoto University. Primary endpoints: Correlation between gene expression profile and chemotherapy effect and Reduction in original tumor size. Started Jul 2007; status: terminated.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • M-VAC Chemotherapy

    Patients receive methotrexate, vinblastine, doxorubicin, and cisplatin.

03

Endpoints

Primary

  • Correlation between gene expression profile and chemotherapy effect

  • Reduction in original tumor size

Secondary

  • Safety of the regimen

  • Overall Survival Rate

  • Reduction in size of metastatic lesions

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