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

Completed · Phase 2

Conditions studied: Head and Neck Cancer, Precancerous Condition

In brief

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.

Key facts

Study ID: NCT01084083
Run by: Eastern Cooperative Oncology Group
People needed: 90
Starts: 2010-08-11
Expected to finish: 2015-01-01
Last updated by the study team: 2023-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

California Cancer Care, Incorporated - Greenbrae — Greenbrae, California, United States
Veterans Affairs Medical Center - Palo Alto — Palo Alto, California, United States
Stanford Cancer Center — Stanford, California, United States
Aurora Presbyterian Hospital — Aurora, Colorado, United States
Boulder Community Hospital — Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
St. Anthony Central Hospital — Denver, Colorado, United States
Porter Adventist Hospital — Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
St. Joseph Hospital — Denver, Colorado, United States
Rose Medical Center — Denver, Colorado, United States
CCOP - Colorado Cancer Research Program — Denver, Colorado, United States
Swedish Medical Center — Englewood, Colorado, United States
Poudre Valley Hospital — Fort Collins, Colorado, United States
Front Range Cancer Specialists — Fort Collins, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center — Grand Junction, Colorado, United States
North Colorado Medical Center — Greeley, Colorado, United States
Sky Ridge Medical Center — Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
McKee Medical Center — Loveland, Colorado, United States
St. Mary - Corwin Regional Medical Center — Pueblo, Colorado, United States
North Suburban Medical Center — Thornton, Colorado, United States
Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus — New Britain, Connecticut, United States
UAB Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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