Clinical trial NCT01634880 (phase 2, status: withdrawn)
Conditions: salivary gland malignancy
ICD codes: Z19.1, Z19.2, R85.614, R87.614, R87.624
Drugs: postoperative radiotherapy and panitumumab
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Reason stopped: 
    lack of accrual.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically determined salivary gland cancer of the major or minor salivary glands
             of the head and neck (any histology) status post potentially curative surgical
             resection with no macroscopic residual disease. Patients should have AJCC 6th edition
             stage III with 1) extracapsular extension, 2) perineural invasion, 3) positive
             surgical margins or 4) high grade histology or stage IVA or IVB.

          -  No distant metastasis.

          -  No prior chemotherapy, biological-targeted therapy (including any prior therapy which
             specifically and directly targets the EGFR pathway), or radiotherapy for head and neck
             cancer.

          -  No more than 10 weeks (minimum of 3 weeks) should elapse between surgery and treatment
             on study.

          -  ECOG performance status of 0-2.

          -  Patients must have normal organ and marrow function.

          -  No prior invasive malignancy unless the disease-free survival is 3 years or more.

          -  Age 18+ years.

          -  Pregnant or breast-feeding women are excluded (see exclusion criteria).

          -  Informed consent must be obtained from all patients prior to beginning research
             related treatment.

          -  Patients should have the ability to understand and the willingness to sign a written
             informed consent document.

        Exclusion Criteria:

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
             unstable angina, recent myocardial infarction (within prior 6 months) uncontrolled
             congestive heart failure, and cardiomyopathy with decreased ejection fraction. All
             patients will have a baseline EKG. If abnormalities consistent with active coronary
             artery disease are detected, the patient will be referred to a cardiologist for
             appropriate evaluation and management prior to treatment on study.

          -  Patients may not be receiving any other investigational agents.

          -  No history of prior malignancy, with the exception of basal carcinoma of the skin or
             in situ cervical cancer, or malignancy that has been treated with a curative intent
             with a 3-year disease-free survival.

          -  Pregnant women are excluded from this study because chemotherapy and radiation therapy
             have the potential for teratogenic or abortifacient effects.

          -  All WOCBP must have a negative serum pregnancy test at baseline, or within 7 days
             prior to receiving investigational product. All WOCBP should be instructed to contact
             the Investigator if they suspect they might be pregnant.

          -  Prior severe infusion reaction to a human monoclonal antibody.