Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab
Condition: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
MeSH terms: Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

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 description: 
      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 with best response, PFS, and OS.

        -  To observe McTNs on circulating tumor cells in blood using a novel polyelectrolyte
           multi-layer (PEM) tethering technology.

        -  To correlate ex vivo response of McTNs to drug treatment with clinical response in order
           to develop a real-time assay to predict response to therapy.

        -  To explore use of circulating tumor (ct) DNA as a biomarker for disease response and
           compare its performance to CA-125.

        -  To examine whether clinical response to ixabepilone with or without bevacizumab differs
           between high and low expressors of class III β-tubulin.
    

Intervention name(s): Ixabepilone; Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response; Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response.
Other intervention name(s): Ixempra; Avastin
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment