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Not Recruiting
Trial ID: NCT01084083
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
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
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
treatment
- 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
ISH
- 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
resection
- Pregnant or nursing
biological: cetuximab
radiation: intensity-modulated radiation therapy (IMRT)
drug: Paclitaxel
drug: Cisplatin
Not Recruiting
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School of Medicine
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Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061