Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT03093155
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ixabepilone — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

First listed
Mar 28, 2017
Start date
Apr 3, 2017
Status verified
Apr 2024
Primary completion
Dec 29, 2022
Completion
Dec 29, 2022

Study Design

Enrollment
78 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ixabepilone
    Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
  • Experimental: Ixabepilone + Bevacizumab
    Ixabepilone 20 mg/m2 days 1, 8, 15 \+ Bevacizumab 10 mg/kg days 1, 15 Q 28 days

Primary Outcome Measure

Progression-free Survival (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab [ Time Frame: Up to 37 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Smilow Cancer Hospital at Yale New HavenNew HavenConnecticut06510-
Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of MarylandBaltimoreMaryland21201-

Find similar trials in New Haven, CT

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Smilow Cancer Hospital at Yale New Haven· New Haven, CTMarlene & Stewart Greenebaum Comprehensive Cancer Center, University of Maryland· Baltimore, MD

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