Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
University of Washington
Study ID
NCT00410826
Phase
PHASE2
Status
Completed

Conditions

  • Stage III Squamous Cell Carcinoma of the Hypopharynx
  • Stage III Squamous Cell Carcinoma of the Larynx
  • Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage III Squamous Cell Carcinoma of the Nasopharynx
  • Stage III Squamous Cell Carcinoma of the Oropharynx
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Larynx
  • Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IV Squamous Cell Carcinoma of the Nasopharynx
  • Stage IV Squamous Cell Carcinoma of the Oropharynx

Eligibility Criteria

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

Interventions

  • erlotinib hydrochloride — DRUG
    Given orally
  • cisplatin — DRUG
    Given IV
  • 3-dimensional conformal radiation therapy — RADIATION
    35 fractions
  • intensity-modulated radiation therapy — RADIATION
    35 fractions
  • quality-of-life assessment — PROCEDURE
    Ancillary studies

Study Details

This randomized phase II trial is studying cisplatin and radiation therapy together with or without erlotinib hydrochloride to compare how well they work in treating patients with stage III or stage IV head and neck cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Giving cisplatin and radiation therapy together with erlotinib hydrochloride may kill more tumor cells. It is not yet known whether cisplatin and radiation therapy are more effective with or without erlotinib hydrochloride in treating head and neck cancer

Key Dates

First listed
Dec 13, 2006
Start date
Jun 30, 2006
Status verified
May 2013
Primary completion
May 31, 2012

Study Design

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

Arms

  • Experimental: Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer)
    Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47. Patients also receive erlotinib hydrochloride PO once daily on days -7 to 47.
  • Active Comparator: Arm II (chemotherapy, radiotherapy)
    Patients receive cisplatin and radiotherapy as in Arm I.

Primary Outcome Measure

Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm [ Time Frame: 12 weeks after the completion of therapy ]

Locations (9)

FacilityCityStateZIPSite coordinators
Alaska Oncology and Hematology LLCAnchorageAlaska99508-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
University of New Mexico Health Science CCOPAlbuquerqueNew Mexico87131-
University of North CarolinaChapel HillNorth Carolina27599-
New Hanover Radiation Oncology CenterWilmingtonNorth Carolina28401-
Medical University of South CarolinaCharlestonSouth Carolina29425-
University of Tennessee Cancer Institute-Boston Cancer Group PLCMemphisTennessee38104-
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattleWashington98109-
Multicare Health SystemTacomaWashington98415-

Find similar trials in Anchorage, AK

By research site
Alaska Oncology and Hematology LLC· Anchorage, AKUniversity of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FLUniversity of New Mexico Health Science CCOP· Albuquerque, NMUniversity of North Carolina· Chapel Hill, NCNew Hanover Radiation Oncology Center· Wilmington, NCMedical University of South Carolina· Charleston, SC

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