Clinical Trial: Study of Gemcitabine+Platinium Salt+Bevacizumab Combination for Metastatic Collecting Duct Carcinoma (BEVABEL)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective Phase II Study of Gemcitabine Plus Platinium Salt in Combination With Bevacizumab (Avastin®) for Metastatic Collecting Duct Carcinoma

Brief Summary: Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinium salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma.

Detailed Summary:
Sponsor: UNICANCER

Current Primary Outcome: Composite endpoint : Objective response rate / Progression-free survival [ Time Frame: 6 months ]

The primary endpoint is composed of:

  • the objective response rate (CR or PR) according to RECIST criteria (V1.1) on the basis of measurable lesions defined at baseline,
  • the progression-free survival (PFS) rate at 6 months , PFS is defined as the absence of disease progression or death


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression-free survival (PFS) [ Time Frame: 2 years max ]
    Progression-free survival (PFS) will be calculated from the date of the first dose of treatment to the date of progression or death (whichever comes first), or last date with no progression
  • The Overall Survival (OS) [ Time Frame: 2 years max ]
    The Overall Survival (OS) will be calculated from the date of the first dose of treatment to the date of death (whatever the cause) or the date of last follow-up
  • The toxicity will be evaluated according to the NCI-CTC scale version 4.0 [ Time Frame: 2 years max ]


Original Secondary Outcome: Same as current

Information By: UNICANCER

Dates:
Date Received: February 9, 2015
Date Started: December 2014
Date Completion:
Last Updated: June 22, 2016
Last Verified: June 2016