Induction Chemotherapy Followed By Cetuximab and Radiation in HPV-Associated Resectable Stage III/IV Oropharynx Cancer

Not Recruiting

Trial ID: NCT01084083


RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high energy x-rays to kill tumor cells. Giving paclitaxel, cisplatin, and cetuximab together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying paclitaxel, cisplatin, and cetuximab to see how well they work when followed by cetuximab and two different doses of intensity-modulated radiation therapy in treating patients with HPV-associated stage III or stage IV cancer of the oropharynx that can be removed by surgery.

Official Title

A Phase II Trial of Induction Chemotherapy Followed by Cetuximab (Erbitux) With Low Dose vs. Standard Dose IMRT in Patients With HPV-Associated Resectable Squamous Cell Carcinoma of the Oropharynx

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

Quynh-Thu Le, MD
Quynh-Thu Le, MD

Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)

Harlan Pinto
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery


Inclusion Criteria:

   - Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx as
   determined by Hematoxylin and eosin (H&E) staining

      - Newly diagnosed disease

      - Resectable disease OR disease that is expected to become resectable after study

      - Stage III, IVA, or IVB disease as determined by imaging studies (computed
      tomography (CT) scan with IV contrast or magnetic resonance imaging (MRI)
      required) and a complete head and neck exam

   - Paraffin-embedded tumor specimen available for central confirmation of HPV-associated
   disease as determined by H&E staining and in-situ hybridization (ISH) for HPV-16 and
   immunohistochemistry (IHC) for p16

      - HPV-associated disease is defined as p16 IHC-positive and/or HPV-16 ISH-positive

      - Non-HPV-associated disease is defined as p16 IHC-negative

      - NOTE: If there is limited tumor material, p16 IHC will be performed before HPV-16

   - Measurable disease of the primary tumor or nodes by clinical and radiographic methods,
   defined as a lesion that is ≥ 2 cm in at least one dimension by clinical exam AND by
   radiographic exam with CT scan or MRI (or a lesion that is ≥ 1 cm in at least one
   dimension if the radiographic exam utilizes spiral CT scan)

   - No primary tumor or nodal metastasis fixed to the carotid artery, skull base, or
   cervical spine

   - No evidence of distant metastases

   - Eastern Cooperative Oncology Group performance status 0-1

   - Granulocytes ≥ 1,000/mm^3

   - Platelet count ≥ 100,000/mm^3

   - Total serum bilirubin ≤ 1.5 mg/dL

   - Creatinine clearance ≥ 60 mL/min

   - Negative pregnancy test

   - Fertile patients must use effective contraception

   - No history of another malignancy (except for carcinoma in situ of the cervix and/or
   nonmelanomatous skin cancer) unless it has been curatively treated and the patient has
   been disease-free for ≥ 2 years

   - Patients with any of the following within the past 6 months are eligible provided they
   have been evaluated by a cardiologist and/or neurologist before study entry:

      - New York Heart Association (NYHA) class III-IV congestive heart failure

      - Cerebrovascular accident or transient ischemic attack

      - Unstable angina

      - Myocardial infarction (with or without ST elevation)

Exclusion Criteria:

   - Prior chemotherapy

   - Prior radiotherapy above the clavicles

   - Prior surgery with curative intent for this disease (complete head and neck exam with
   biopsy allowed)

   - Prior therapy specifically and directly targeting the EGFR pathway

   - Prior severe infusion reaction to a monoclonal antibody

   - Uncontrolled diabetes, uncontrolled infection despite antibiotics, or uncontrolled
   hypertension within the past 30 days

   - Concurrent illness likely to interfere with study therapy or to prevent surgical

   - Pregnant or nursing


biological: cetuximab

radiation: intensity-modulated radiation therapy (IMRT)

drug: Paclitaxel

drug: Cisplatin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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