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Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT01412229 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-11-23

Study results available
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Summary

This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy.

Conditions

Interventions

DRUG

Cetuximab

Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.

DRUG

Nab-paclitaxel

Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.

DRUG

Carboplatin

Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Jared Weiss, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-06-20
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01412229 on ClinicalTrials.gov