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



Status:Archived
Conditions:Skin Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011

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A Multicenter Randomized Phase II Study of Erlotinib, Cisplatin and Radiotherapy Versus Cisplatin and Radiotherapy in Patients With Stage III and IV Squamous Cell Carcinoma of the Head and Neck


RATIONALE: 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.

PURPOSE: 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.


PRIMARY OBJECTIVE:

I. Compare the complete response rate in patients with locally advanced head and neck
cancer, treated with cisplatin, radiotherapy and erlotinib versus cisplatin and radiotherapy
alone.

SECONDARY OBJECTIVES:

I. Evaluate whether the addition of erlotinib increases the acute and long term toxicities
of cisplatin and radiotherapy, in patients with locally advanced head and neck cancer.

II. Compare the disease-free and overall survivals of patients with locally advanced head
and neck cancer treated with cisplatin and radiotherapy, with and without erlotinib.

III. Evaluate whether the symptomatic improvement observed in the first week of erlotinib
alone predicts for complete response and long term disease control.

IV. Correlate EGFR, p16 and ERCC-1 expression with response outcome to therapy with
cisplatin and radiation with and without erlotinib.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: 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 oral erlotinib hydrochloride once daily on days -7 to 47.

Arm II: Patients receive cisplatin and undergo radiotherapy as in arm I.

Within 10-14 weeks after completion of study treatment, patients with N2 or N3 disease at
the time of screening undergo a neck dissection.

After completion of study treatment, patients are followed periodically for 5 years.


We found this trial at
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
University of Miami Hospital The University of Miami changed the face of modern health care...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Albuquerque, NM
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Anchorage, Alaska 99508
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Anchorage, AK
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101 Manning Dr
Chapel Hill, North Carolina 27599
(919) 966-4131
University of North Carolina Hospital at Chapel Hill The UNC Health Care System is a...
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Chapel Hill, NC
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Memphis, Tennessee 38104
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Memphis, TN
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
(253) 403-5200
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
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Tacoma, WA
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Wilmington, North Carolina 28401
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Wilmington, NC
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