CompletedPhase 2

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

United States90 participantsStarted 2010-08-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

24-month Progression-free Survival

Timeframe: assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry

Trial details

NCT IDNCT01084083

SponsorEastern Cooperative Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2015-01

Results submitted2015-08-17