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Identification of Gene Expression Signature for Panitumumab Sensitivity in Untreated Locally Advanced SCCHN

NCT01305772 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2014-08-29

Study results available
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Summary

The purpose of this study was to identify which cancer-related genes are turned on or turned off in order to determine how well a patient will respond to the study drug, panitumumab. Panitumumab was added to standard adjuvant or primary radiation therapy. There were subjects that receive surgery followed by therapy and subjects that receive radiation therapy without surgery.

Subjects entering this study had locally advanced disease that can be treated with surgery and/or radiation therapy. Fresh frozen tumor tissue were available for genomics analysis prior to initiating panitumumab therapy. If fresh frozen tissue was not available at time of consent, a biopsy was required to participate in this trial.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Panitumumab

Single dose Panitumumab 9mg/kg IV (in the vein) prior to definitive therapy (surgery or radiation therapy). Two additional doses of panitumumab 9mg/kg IV may be given at weeks 1 \& 4 of RT alone or weeks 1 \& 4 of cisplatin/RT if they tolerated first dose of panitumumab.

PROCEDURE

Surgery

Second biopsy was taken from surgical resection tissue (when possible obtained pre and post panitumumab biopsies from the same site).

PROCEDURE

Radiation Therapy

Radiation therapy was initiated within 8 weeks after surgery, or as soon as possible.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Neal Ready

    lead OTHER

Principal Investigators

  • Neal Ready, MD, PhD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-03-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01305772 on ClinicalTrials.gov