NCT03093155

Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab

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 Peritoneal Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Ixabepilone	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
DRUG	Bevacizumab	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.

Timeline

• Start date: 2017-04-03
• Primary completion: 2022-12-29
• Completion: 2022-12-29
• First posted: 2017-03-28
• Last updated: 2024-05-14
• Results posted: 2024-05-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study