Clinical trial: Adjuvant Erlotinib After Completing Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (NCT00079053)

Eligibility criteria:
DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous cell carcinoma of the head and neck

               -  Stage III, IVA, or IVB

          -  Must have completed cisplatin- or carboplatin-based chemoradiotherapy within the past
             4-12 weeks

               -  Prior radiotherapy must have been given with a radical intent with receipt of at
                  least 90% of planned dose

          -  No evidence of disease or presence of inoperable minimal residual disease, defined by
             1 of the following:

               -  Complete response at primary tumor site and nodes (with or without nodal surgery
                  after chemoradiotherapy)

               -  Negative lymph node status (by physical or radiological exam) AND persistent
                  tumefaction less than 25% of original tumor size or residual mass due to scarring

          -  Tumor tissue samples available for EGFRvIII mutation analysis

          -  No known brain metastasis

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute granulocyte count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  ALT/AST < 2 times upper limit of normal (ULN)

          -  Bilirubin < ULN (unless due to Gilbert's syndrome)

        Renal

          -  Creatinine < 1.5 times ULN

        Cardiovascular

          -  No myocardial infarction within the past year

          -  No cardiac ventricular arrhythmias requiring medication

          -  No history of cardiac disease

          -  No uncontrolled high blood pressure

          -  No unstable angina

          -  No congestive heart failure

        Ophthalmic

          -  No history of severe dry eye syndrome, Sjögren's syndrome, or keratoconjunctivitis
             sicca

          -  No severe exposure keratopathy

          -  No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)

          -  No abnormal corneal sensitivity test (Schirmer test or similar tear production test)

          -  No disorder that might increase the risk for epithelium-related complication (e.g.,
             bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)

          -  No congenital abnormality (e.g., Fuch's dystrophy)

          -  No ocular inflammation or infection

        Gastrointestinal

          -  Able to take oral medication

          -  No gastrointestinal (GI) tract disease requiring IV alimentation

          -  No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)

          -  No active peptic ulcer disease

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No serious active infection

          -  No other serious underlying medical condition that would preclude study participation

          -  No prior allergic reaction to compounds of similar chemical or biological composition
             to erlotinib

          -  No other malignancy with the past 5 years except adequately treated non-melanoma skin
             cancer (unless in the same area treated with radical radiotherapy) or carcinoma in
             situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  See Disease Characteristics

          -  Recovered from prior chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  Recovered from prior radiotherapy

        Surgery

          -  See Disease Characteristics

          -  No prior surgical procedure affecting absorption

          -  No concurrent ophthalmic surgery

        Other

          -  More than 4 weeks since other prior investigational drugs

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy

          -  Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased
             vigilance with respect to INR

          -  Concurrent nasogastric or gastrostomy tube feeding for dysphagia allowed provided
             there is no evidence of significant residual mucositis (i.e., > grade 1)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 120 Years

Patient description (medical language): A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable.

Patient description (patient's own words): I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine.

Does the patient match the trial criteria? Contradiction