Trial of Bevacizumab and Ixabepilone for Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Portland, Oregon.

Sponsor
Providence Health & Services
Study ID
NCT01057212
Phase
PHASE2
Status
Terminated

Conditions

  • Non-squamous Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ixabepilone — DRUG
    Ixabepilone will be administered intravenously, 16 mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the first six patients enrolled. Ixabepilone will be administered intravenously, 20mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the remaining 40 patients enrolled.
  • bevacizumab — DRUG
    Bevacizumab will be administered intravenously, 10 mg/kg, every two weeks.

Study Details

This is a non-randomized, open-label, single arm phase II trial of the combination of bevacizumab and ixabepilone in patients with advanced- or metastatic non-squamous NSCLC progressive after first or second-line therapy. The main objective is to evaluate the progression-free survival in patients with advanced or metastatic non-squamous NSCLC being treated with ixabepilone and bevacizumab.

Key Dates

First listed
Jan 27, 2010
Start date
Feb 28, 2010
Status verified
Sep 2015
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab and Ixabepilone
    Bevacizumab will be administered intravenously, 10 mg/kg, every two weeks. Ixabepilone will be administered intravenously, 16 mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the first six patients enrolled. Ixabepilone will be administered intravenously, 20mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule to the remaining 40 patients.

Primary Outcome Measure

progression-free survival [ Time Frame: at week 8, week 16, and every 8 weeks until disease progression or removal from study ]

Locations (1)

FacilityCityStateZIPSite coordinators
Providence Portland Medical CenterPortlandOregon97213-

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By research site
Providence Portland Medical Center· Portland, OR

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