At a glance
ClinicalIndex Comparison Record- ✓Platinum-resistant/refractory recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer (platinum-free interval <6 months)
- ✓Measurable disease by RECIST v1.1 with at least one target lesion (≥20 mm by conventional imaging or ≥10 mm by CT/MRI)
- ✓Prior treatment with taxanes (any number of prior lines allowed)
- ✓ECOG performance status 0–2
- ✕Brain or leptomeningeal involvement of cancer
- ✕History of other invasive malignancy within the past 5 years (except non-melanoma skin cancer)
- ✕Uncontrolled cardiac disease: hypertension, angina, heart failure, or arrhythmias (NYHA III–IV) within 6 months
- ✕Active infection/sepsis requiring IV antibiotics or unstable medical conditions
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Ixabepilone and Bevacizumab for Epithelial Ovarian Cancer and 2 related conditions. Completed, enrolled 78 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.