Intensity-Modulated Radiation Therapy, Pemetrexed, and Erlotinib in Treating Patients With Recurrent or Second Primary Head and Neck Cancer

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT00573989
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • erlotinib hydrochloride — DRUG
  • pemetrexed disodium — DRUG
  • quality-of-life assessment — PROCEDURE
  • intensity-modulated radiation therapy — RADIATION

Study Details

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as pemetrexed and erlotinib, may make tumor cells more sensitive to radiation therapy. Erlotinib and pemetrexed may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving intensity-modulated radiation therapy together with pemetrexed and erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with intensity-modulated radiation therapy and pemetrexed and to see how well they work in treating patients with recurrent or second primary head and neck cancer.

Key Dates

First listed
Dec 14, 2007
Start date
Mar 31, 2008
Status verified
Dec 2018
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017

Study Design

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

Arms

  • Experimental: Erlotinib
    Erlotinib

Primary Outcome Measure

Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I) [ Time Frame: 56 Days ]

Locations (2)

FacilityCityStateZIPSite coordinators
UNC Linberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Wake Forest University Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-1096-

Find similar trials in Chapel Hill, NC

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
UNC Linberger Comprehensive Cancer Center· Chapel Hill, NCWake Forest University Comprehensive Cancer Center· Winston-Salem, NC

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