Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer

NCT00741988 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2021-12-15

Study results available
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Summary

This is a multicenter, non-randomized, Phase II study of patients with previously untreated NSCLC not amenable to radiotherapy or surgical treatment. The planned enrollment for this trial is 78 patients (including a 10% rate for inevaluable patients). There will be a total of 39 patients in each cohort (Cohorts A and B).

Conditions

Interventions

DRUG

Ixabepilone

ixabepilone 30 mg/m2

DRUG

Carboplatin

carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.

DRUG

Bevacizumab

bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY
  • Genentech, Inc.

    collaborator INDUSTRY
  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • David R Spigel, MD · Sarah Cannon Research Insititute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00741988 on ClinicalTrials.gov