Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: cetuximab; cisplatin; intensity-modulated radiation therapy; Nab-Paclitaxel
Intervention description: cetuximab; cisplatin; IMRT; Nab-Paclitaxel
Intervention MeSH terms: Paclitaxel; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive
             tract

          -  Recurrent disease or second primary SCC

               -  Recurrence or second primary must be confined to the head and neck above the
                  clavicles (loco-regional recurrence)

               -  Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated to
                  ≥ 45 Gy

               -  More than one recurrence allowed provided the first recurrence occurred > 6
                  months after the completion of prior radiotherapy

          -  Unresectable disease OR has high-risk features after resection (e.g., positive margins
             and/or extracapsular extension)

               -  No signs of carotid exposure

          -  No primary nasopharyngeal or salivary gland tumor

          -  Equivocal pulmonary nodes on chest CT scan allowed provided they are < 1 cm, cannot be
             safely biopsied, or are negative on PET scan

          -  No distant metastasis

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100%

          -  ANC ≥ 2,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

          -  Bilirubin < 1.5 mg/dL

          -  AST or ALT < 2 times upper limit of normal

          -  Creatinine clearance ≥ 50 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Able to submit prior radiotherapy records to assure that the spinal cord tolerance is
             not exceeded

          -  No active cardiac disease, including any of the following:

               -  Unstable angina

               -  Uncontrolled hypertension

               -  Myocardial infarction within the past 6 months (unless successfully treated with
                  coronary artery bypass graft or percutaneous transluminal coronary angioplasty)

               -  Uncontrolled arrhythmia

               -  Congestive heart failure

               -  At least 3 heart-related hospitalizations within the past year

          -  No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within
             the past year

          -  No concurrent medical illness that would impair patient tolerance to therapy or limit
             survival

          -  No other invasive malignancy within the past 2 years

          -  No pre-existing peripheral sensory neuropathy ≥ grade 2

          -  No prior severe infusion reaction to a monoclonal antibody

          -  No prisoners or individuals who are compulsorily detained (involuntarily incarcerated)
             for treatment of either a psychiatric or physical (e.g., infectious) illness

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from prior surgery

          -  Prior cisplatin and cetuximab allowed

          -  At least 6 months since prior radiotherapy or chemotherapy

          -  No prior radiotherapy > 75 Gy

          -  No prior chemotherapy for recurrent head and neck cancer

               -  Prior chemotherapy as a component of the primary treatment allowed

          -  No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and
             neck cancer

               -  Patients with a new primary head and neck cancer whose prior primary head and
                  neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy
                  are eligible provided it has been > 6 months since treatment