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Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection

NCT01927744 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-11-26

Study results available
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Summary

The goal of this clinical research study is to learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied.

In this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

This is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin, and carboplatin are all FDA approved and commercially available for the treatment of SCCHN.

Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions

Interventions

DRUG

Docetaxel

75 mg/m2 by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.

DRUG

Erlotinib

150 mg by mouth daily continuously until the day before surgery.

OTHER

Placebo

150 mg by mouth daily continuously until the day before surgery.

BEHAVIORAL

Questionnaires

Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery.

BEHAVIORAL

Phone Call

Phone call made to patient 1 time each year after the end of treatment visit.

DRUG

Chemotherapy

Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • The Kadoorie Charitable Foundations

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Xiuning Le, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-16
Primary Completion
2025-01-06
Completion
2025-01-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT01927744 on ClinicalTrials.gov