Clinical Trial: Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab

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

Official Title: A Randomized Phase II Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab in Recurrent or Persistent Platinum-resistant/Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peri

Brief Summary: This is a randomized, two-arm, open-label Phase II multicenter study designed to examine the effects of adding bevacizumab to ixabepilone for the treatment of patients who have recurrent or persistent platinum-resistant/refractory epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. Its primary objective is to assess whether adding bevacizumab to ixabepilone improves progression-free survival in its target population. Study participants will be stratified by (a) study site and (b) previous receipt of bevacizumab prior to randomization.

Detailed Summary:

The primary objective of this study is as follows:

• To assess the activity of ixabepilone with bevacizumab compared to ixabepilone alone in patients with recurrent or persistent platinum-resistant/refractory epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. We will assess this by comparing the ixabepilone +bevacizumab (experimental) arm to the ixabepilone-alone (control) arm for an improvement in median progression free survival (PFS).

The secondary objectives of this study are as follows:

• To compare the experimental arm to the control arm for increases in objective response rate (ORR) and durable disease control rate (DDCR).
• To compare the experimental arm to the control arm for an increase in overall survival (OS).
• To assess the safety profile of ixabepilone in combination with bevacizumab in ovarian, fallopian tube, or primary peritoneal cancer patients.
• To assess whether prior treatment with bevacizumab impacts future response to bevacizumab in combination with ixabepilone.

In addition to the primary and secondary objectives of this study, there are additional exploratory/correlative objectives. The exploratory/correlative objectives of this study are as follows:

• To characterize number, length and composition (e.g., class III β-tubulin expression) of microtentacles (McTNs) isolated from circulating tumor cells isolated from whole blood of patients undergoing treatment with ixabepilone with or without bevacizumab, and correlate
  Sponsor: Yale University
  

  Current Primary Outcome: Progression-free survival (PFS) differences between Ixabepilone alone and Ixabepilone + Bevacizumab [ Time Frame: 4 Years ]

  Progression-free survival (PFS), the primary endpoint, will be defined as the length of time from randomization to disease recurrence, disease progression, or death for any reason.
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Yale University
  

  Dates:
  Date Received: March 22, 2017
  Date Started: April 3, 2017
  Date Completion: March 2022
  Last Updated: April 17, 2017
  Last Verified: April 2017