Radiation + Cisplatin or Panitumumab in Locally Advanced Stage III or Stage IV Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: panitumumab; cisplatin; 3-dimensional conformal radiation therapy; accelerated radiation therapy; intensity-modulated radiation therapy
Intervention description: Given IV; Given IV; Patients undergo radiotherapy; Patients undergo accelerated fractionation radiotherapy; Patients undergo radiotherapy
Intervention MeSH terms: Panitumumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx; stage IV squamous cell carcinoma of the oropharynx; stage III verrucous carcinoma of the oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage IV verrucous carcinoma of the oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation
      therapy in higher doses over a shorter period of time may kill more tumor cells and have
      fewer side effects. 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. Monoclonal antibodies, such as panitumumab, 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. It is not yet known whether giving
      standard radiation therapy together with high-dose cisplatin is more effective than giving
      higher-dose radiation therapy together with panitumumab in treating patients with locally
      advanced head and neck cancer.

      PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens to see
      how well they work when given together with cisplatin or panitumumab in treating patients
      with locally advanced stage III or stage IV head and neck cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically and/or cytologically confirmed (primary lesion or regional lymph nodes)
             squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx

               -  Locally advanced disease, defined by any of the following criteria:

                    -  Any T, N+, M0

                    -  T3-4, N0, M0

          -  No current history of unknown primary squamous cell carcinoma of the head and neck,
             primary nasopharyngeal, paranasal, or salivary gland tumors of the head and neck

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Absolute granulocyte count ≥ 1.5 x 10^9/L

          -  Platelet count ≥ 100 x 10^9/L

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST or ALT ≤ 3 times ULN

          -  Creatinine clearance > 50 mL/min

          -  Magnesium > 0.5 mmol/L

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 6 months after
             completion of study treatment

          -  Must be accessible for treatment and follow-up

          -  Able (sufficiently fluent) and willing to complete the quality of life (QOL) and
             swallowing QOL questionnaires in either English or French

          -  Must be assessed by a radiation oncologist and medical oncologist and deemed suitable
             for study participation

          -  No other malignancies within the past 5 years, except adequately treated nonmelanoma
             skin cancer, curatively treated in-situ cancer of the cervix, or other curatively
             treated solid tumors

          -  No history of allergic or hypersensitivity reactions to any of the study drugs or
             their excipients

          -  No prior or concurrent interstitial lung disease (e.g., pneumonitis or pulmonary
             fibrosis) on baseline CT scan

          -  No peripheral neuropathy ≥ grade 2 (CTCAE v3.0)

          -  No hearing loss/tinnitus ≥ grade 3 (CTCAE v3.0)

          -  No thromboembolic event within the past 12 months despite being treated with
             anticoagulation drugs

               -  Prior thromboembolic event > 12 months allowed provided patient is stable on
                  anticoagulation or on preventative anticoagulation

          -  None of the following allowed:

               -  Myocardial infarction within the past 12 months

               -  Uncontrolled severe congestive heart failure

               -  Unstable angina

               -  Active cardiomyopathy

               -  Unstable ventricular arrhythmia

               -  Uncontrolled hypertension

               -  Uncontrolled psychiatric disorder

               -  Active serious infection

               -  Active peptic ulcer disease

               -  Any other medical condition that might interfere with protocol therapy delivery

        PRIOR CONCURRENT THERAPY:

          -  No prior surgical treatment except diagnostic biopsy for this disease

          -  No prior induction chemotherapy for this disease

          -  No prior radiation to the head and neck region that would result in overlap of fields
             for this study

          -  No prior cisplatin or carboplatin chemotherapy

          -  No prior targeted anti-EGFR therapy of any kind

          -  At least 30 days since any prior investigational agent

          -  No concurrent granulocytic growth factors (e.g., filgrastim [G-CSF]) during
             radiotherapy

          -  No concurrent erythropoietic growth factors, pilocarpine, amifostine, other anticancer
             therapy (e.g., cytotoxic agents, biological response modifiers, immunotherapy, or
             hormonal therapy), or other investigational drug therapy

          -  The following radiological investigations must be done within 8 weeks of
             randomization:

               -  MRI or CT of the head and neck

               -  CT chest