Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle
      formulation 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. Paclitaxel
      albumin-stabilized nanoparticle formulation may make tumor cells more sensitive to radiation
      therapy. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation
      together with cisplatin and cetuximab may kill more tumor cells.

      PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel
      albumin-stabilized nanoparticle formulation when given together with cisplatin, cetuximab,
      and radiation therapy to see how well they work in treating patients with locally advanced
      stage III or stage IV head and neck cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle
           formulation when combined with cisplatin, cetuximab, and radiotherapy in patients with
           local-regionally advanced squamous cell carcinoma of the head and neck. (Phase I)

        -  To evaluate the disease-free survival of patients treated with this regimen. (Phase II)

      Secondary

        -  To identify dose-limiting toxicities in these patients treated with this regimen. (Phase
           I)

        -  To assess the safety and tolerability of this regimen. (Phases I and II)

        -  To assess progression-free survival and survival of patients treated with this regimen.
           (Phase I)

        -  To assess overall survival in patients treated with this regimen. (Phase II)

        -  To assess response rates in patients treated with this regimen. (Phases I and II)

      OUTLINE: This is a multicenter, phase I dose-escalation study of paclitaxel
      albumin-stabilized nanoparticle formulation followed by a phase II study.

      Patients receive cetuximab IV over 120 minutes in week 1. Patients then receive cetuximab IV
      over 60 minutes, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes,
      and cisplatin IV over 60 minutes once weekly in weeks 2-8. Patients also undergo 3D conformal
      or intensity-modulated radiotherapy over 30 minutes on days 1-5 in weeks 2-8.

      After completion of study treatment, patients are followed every 3 months for 2 years and
      then every 6 months for 4 years.
    

Intervention name(s): Cetuximab; Cisplatin; Nab-Paclitaxel; intensity-modulated radiation therapy
Intervention type(s): Biological; Drug; Drug; Radiation
Intervention description(s): Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor; Cisplatin is an anti-cancer chemotherapy drug; paclitaxel albumin-stabilized nanoparticle formulation; intensity-modulated radiation therapy
Other intervention name(s): Platinol; Abraxane
Intervention MeSH terms: Paclitaxel; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; tongue cancer