Conditions: Head and Neck Cancer
Keywords: recurrent hypopharynx Cancer recurrent larynx Cancer recurrent verrucous carcinoma squamous cell carcinoma recurrent oral cavity cancer recurrent metastatic occult primary cancer recurrent oropharynx cacner recurrent paranasal sinus and nasal cavity cancer tongue cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 37
Healthy volunteers: no

Brief summary:
RATIONALE: 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. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.

Detailed description:
OBJECTIVES:

Primary

* To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma of the head and neck.

Secondary

* To determine the progression-free survival and local-regional progression in these patients.
* To identify and estimate the incidence rate of acute and late toxicities associated with this treatment regimen.
* To determine the pattern of disease progression in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.

Arms:
arm 1: Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy

Interventions: intervention 1: cetuximab intervention 2: cisplatin intervention 3: intensity-modulated radiation therapy intervention 4: Nab-Paclitaxel
Intervention descriptions: intervention 1: cetuximab intervention 2: cisplatin intervention 3: IMRT intervention 4: Nab-Paclitaxel

Protocol document: