Erlotinib and Docetaxel With Concomitant Boost Radiation Therapy (XRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00113347
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Beginning on Day 2 of treatment, 100, 125, or 150 mg by mouth once a day every day while on treatment, except on days docetaxel is received.
  • Docetaxel — DRUG
    15 mg/m\^2 or 20 mg/m\^2 by vein over 15 to 30 minutes on Days 1, 8, 15, and 22 of treatment.
  • Radiation Therapy — RADIATION
    Radiation therapy to head/neck beginning on day 1 of treatment once daily 5 times per week (Monday through Friday), delivered in 40 fractions.

Study Details

The goal of this clinical research study is to find the highest safe dose of the drugs OSI-774 and docetaxel that can be given together along with radiation treatment for advanced head and neck cancer.

Key Dates

First listed
Jun 8, 2005
Start date
Apr 30, 2005
Status verified
Feb 2012
Primary completion
Apr 30, 2011
Completion
Apr 30, 2011

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib + Docetaxel
    Erlotinib 100, 125, or 150 mg orally daily except days receive Docetaxel 15 mg/m\^2 or 20 mg/m\^2 intravenously with Concomitant Boost Radiation to Head/Neck

Primary Outcome Measure

Maximum tolerated dose (MTD) of erlotinib and docetaxel during concomitant boost radiation [ Time Frame: 6 weeks of treatment, followed ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
UT MD Anderson Cancer Center· Houston, TX

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