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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00954226
Phase
PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Aug 7, 2009
Start date
Aug 5, 2009
Status verified
Aug 2025
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (standard-dose erlotinib hydrochloride)
    Patients receive standard-dose erlotinib hydrochloride PO QD for 2-3 weeks (up to 8 weeks if surgery is delayed).
  • Experimental: Arm II (high-dose erlotinib hydrochloride)
    Patients receive high-dose erlotinib hydrochloride PO QD for 2-3 weeks (2-8 weeks for current smokers or up to 8 weeks if surgery is delayed).

Primary Outcome Measure

Change in modulation of the biomarker phospho-Akt in tumor specimens [ Time Frame: From baseline to surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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