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Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma

NCT01794845 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-05-11

Study results available
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Summary

Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.

Conditions

Interventions

DRUG

Erbitux

Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.

DRUG

Taxotere

Taxotere : 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.

RADIATION

Low Dose Fractionated Radiation Therapy

Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Matthew C Abramowitz, MD · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-03
Primary Completion
2016-06-07
Completion
2016-06-07

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 NCT01794845 on ClinicalTrials.gov