Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Phase III Trial to Compare Radiation Therapy Alone With Radiation Therapy and Concomitant Anti-EGFr Antibody (C225) for Locally Advanced Squamous Cell Carcinomas of the Head and Neck
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if radiation therapy is more effective with or without cetuximab for cancer of the oropharynx, hypopharynx, or larynx.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without cetuximab in treating patients who have stage III or stage IV cancer of the oropharynx, hypopharynx, or larynx.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically proven advanced squamous cell carcinoma of the oropharynx, hypopharynx, or larynx

  * Stage III OR
  * Stage IV without distant metastases
* Measurable disease
* Tumor tissue available for immunohistochemical assay of epidermal growth factor receptor expression

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 1 year

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* SGOT and SGPT no greater than 2 times upper limit of normal

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min
* Calcium normal

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Medically able to withstand a course of definitive radiotherapy
* No medical or psychologic condition that would preclude informed consent or compliance
* No other malignancy within the past 3 years except basal cell skin cancer or preinvasive carcinoma of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior cetuximab or other murine monoclonal antibody

Chemotherapy:

* At least 3 years since prior systemic chemotherapy
* No concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy to head and neck
* No other concurrent radiotherapy

Surgery:

* No prior surgery for indicator lesion except biopsy
* Study radiotherapy must not be a part of a postoperative regimen after primary surgical resection
B: Inclusion Criteria:

* Histologically or cytologically confirmed, head and neck or lung cancers
* Any NSCLC histology is eligible. Stages I, II, IIIA (T3N1 only) or recurrent NSCLC that will be managed with surgery are eligible.
* Primary tumors of any head and neck (oral cavity, oropharynx, hypopharynx, or larynx) or lung site will be included.
* Surgical resection of head and neck or lung must be planned, either as primary treatment or salvage. Patients must have tissue available prior to receiving drug(s).
* Age greater then 18 years.
* ECOG performance status 0-2.
* Women of childbearing potential (WOCBP) must have:

  1. A negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration
  2. Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped.
  3. Ability to take oral medication (dasatinib must be swallowed whole).
  4. Concomitant Medications
* Patients agrees to discontinue St. Johns Wort while receiving dasatinib therapy (discontinue St. Johns Wort at least 5 days before starting dasatinib).
* Patient agrees that IV biphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
* Adequate hematologic, renal and hepatic function.
* Have signed written informed consent including a HIPPA form according to institutional guidelines.

Exclusion Criteria:

* Subjects who fail to meet the above criteria.
* Prior therapy for head and neck or lung cancers is allowed, with the exception of EGFR inhibitors. Any systemic therapy should have been completed at least 30 days prior to study enrollment.
* Pregnancy or breastfeeding. Women (patients or partners of male patients) of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy.
* Any unresolved chronic toxicity grade greater or equal to 2 from previous anticancer therapy (except alopecia and anemia).
* Acute hepatitis, known HIV, or active uncontrolled infection.
* Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment.
* Prior treatment with an EGFR inhibitor (tyrosine kinase inhibitor).
* Cardiac Symptoms; any of the following should be considered for exclusion:

  1. History of thromboembolic event or other condition currently requiring anticoagulation with warfarin (Coumadin). Patients whose therapy is changed to heparin is eligible.
  2. History of any other cancer except basal cell carcinoma of the skin.
  3. Concurrent medical condition which may increase the risk of toxicity, including:

     \* Pleural or pericardial effusion of any grade
  4. History of significant bleeding disorder unrelated to cancer, including:

     * Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease).
     * Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).
     * Ongoing or recent (≤ 3 months) significant gastrointestinal bleeding.
  5. Concomitant Medications, any of the following should be considered for exclusion:

     \* Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)
  6. Women who:

     * are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug,
     * have a positive pregnancy test at baseline, or
     * are pregnant or breastfeeding.
  7. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.
C: Inclusion Criteria:

* Patients with upper aerodigestive tract carcinomas (all sites included) having surgical resection and eligible for post-operative radiation + cisplatin.
* Patient having a tumoral biopsy (0.5 - 1 cm3) stored in liquid nitrogen at time of surgical resection (patients with small tumors located in larynx for instance will not be included)
* Patients receiving post-operative radiation (\>=60 Gy on tumor bed and/or cervical area), associated with cisplatin, 6 weeks after surgery at the latest.

Exclusion Criteria:

* previous history of cancer (except skin basal cell carcinoma)
D: Inclusion Criteria:

* Cytological or pathological documented squamous cell carcinoma of oral cavity, oropharynx, larynx, and hypopharynx; patients with nasopharyngeal carcinoma can be included if the patients have grades I or II tumors according to the World Health Organization (WHO) classification
* Stage III or IV according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, Sixth Edition (2002)
* Unresectable or resection with significant morbidity
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Measurable Disease, defined according to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
* Bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 x ULN
* Calculated creatinine clearance \>= 55ml/min (using the Cockcroft-Gault formula)
* Platelet count \>= 100 x 10\^9 /L
* Absolute neutrophil count (ANC) \>= 1.25 x 10\^9 /L
* Signed informed consent
* Male and female patients with reproductive potential must use an acceptable contraceptive method
* Authorization from a dentist to begin radiation therapy

Exclusion Criteria:

* Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
* Inability or unwillingness to comply with radiotherapy
* Evidence of clinically significant congestive heart failure; patients must be able to tolerate hydration required during cisplatin chemotherapy
* Diarrhea \> grade 1 at the time of enrollment
* Prior radiotherapy, chemotherapy, or investigational treatment for squamous cell carcinoma of head and neck
* Prior treatment with an investigational or marketed inhibitor of the EGFR pathway
* Use of cytochrome P450 3A4 (CYP3A4) inducers
* Presence of systemic metastases (M1)
* Pregnant or breast-feeding women
* Known human immunodeficiency virus (HIV) infection

Answer: A