TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer. (TRYHARD)

This is an interventional treatment trial for Non-HPV Locally Advanced Head and Neck Cancer Read More

Inclusion criteria:

• Patients must have histologically or cytologically confirmed diagnosis (from primary lesion and/or lymph nodes) of Squamous Cell Cancer of the oropharynx, hypopharynx or larynx (For patients with oropharynx primary, the tumor must be negative for p16 by immunohistochemistry).
• Patients with selected Stage III or IV disease (T2 N2-3 M0, T3-4 any N M0, T1 N2b, N2c or N3 p16 negative oropharynx cancer or T1-2 any N+ hypopharynx cancer) including no distant metastases.
• History/Physical examination by a Radiation Oncologist and Medical oncologist prior to entering the study.
• Examination by an ears, nose, throat (ENT) or Head & Neck Surgeon including laryngopharyngoscopy prior to entering the study.
• Patients must have a chest CT scan, or positron emission tomography (PET)/CT scan to rule out metastatic disease
• Patients must have a contrast enhanced CT scan or MRI or PET/CT scan of the tumor site and neck nodes prior to entering the study.
• Patients must have an EKG and echocardiogram (ECHO) or multigated acquisition (MUGA) scan prior to entering the study.
• Patients must have Zubrod Performance Status of 0-1.
• Patients must be ≥ 18 years of age.

• Patients must have normal organ and marrow function as defined below:

  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
  • Platelets ≥ 100,000 cells/mm3
  • Hemoglobin ≥ 8.0 g/dl
  • Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min
  • Total bilirubin < 2 x the institutional upper limit of normal
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x the institutional upper limit of normal
• Patient must have magnesium, calcium, glucose, potassium and sodium levels within normal limits
• Women of childbearing potential must have a negative pregnancy test prior to registration.
• Patients of reproductive potential must practice effective contraception while on study and for at least 60 calendar days following treatment.
• All patients must sign an informed consent prior to enrollment.
• Patients must comply with the treatment plan and follow-up schedule.

Exclusion criteria:

• Patients with simultaneous primaries or bilateral tumors.
• Patients who have had gross total excision of the primary tumor.
• Patients with initial surgical treatment, radical or modified neck dissection.
• Patients who received prior systemic chemotherapy for the study cancer.
• Patients who received prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
• Patients with primary tumor of oral cavity, nasopharynx, sinuses or salivary glands.
• Prior allergic reaction to the study drugs.
• Patients who have had prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor 2 (HER2) pathway.
• Patients who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment);
• Pregnant women or sexually active patients not willing or able to use medically acceptable forms of contraceptive method while on treatment.

• Patients with severe, active co-morbidity, defined as follows:

  • Uncontrolled cardiac disease, such as uncontrolled hypertension, unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Left ventricular ejection fraction < 45%
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 calendar days prior to registration
  • Hepatic insufficiency resulting in clinical jaundice and/or Coagulation defects
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition