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Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer

NCT00954226 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-09-05

No results posted yet for this study

Summary

This randomized phase Ib trial studies standard-dose or high-dose erlotinib hydrochloride before surgery in treating patients with head and neck cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

  • Recurrent Head and Neck Carcinoma
  • Recurrent Salivary Gland Carcinoma
  • Recurrent Skin Carcinoma
  • Skin Squamous Cell Carcinoma

Interventions

DRUG

Erlotinib Hydrochloride

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Xiuning Le · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-05
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT00954226 on ClinicalTrials.gov