Clinical trial NCT00265941 (phase 3, status: active, not recruiting)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: cetuximab, cisplatin
SMILES: [H][C@]12SCC(COC(C)=O)=C(N1C(=O)[C@H]2NC(=O)C(=N/OC)\C1=CSC(N)=N1)C(O)=O, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility criteria:

        Inclusion criteria:

          -  Pathologically (histologically or cytologically) proven (from primary lesion and/or
             lymph nodes) diagnosis of squamous cell carcinoma of the oropharynx, hypopharynx, or
             larynx;

          -  Selected stage III or IV disease (T2N2-3M0, T3-4 any N M0); Note: Patients with T1,
             any N, or T2N1 tumors are not eligible.

          -  Appropriate stage for protocol entry, including no distant metastases, based upon the
             following minimum diagnostic workup:

          -  History/physical examination within 4 weeks prior to registration, including
             assessment of weight and weight loss in past 6 months and an examination by a Medical
             Oncologist;

          -  Chest x-ray (or Chest CT scan or PET/CT scan) within 6 weeks prior to registration;

          -  CT scan or MRI of the head and neck (of the primary tumor and neck nodes) or PET/CT
             scan within 6 weeks prior to registration; see Section 6.11 for details of PET scans.
             Note: A PET/CT can only be used instead of a CT scan or MRI if the CT is a high
             quality scan with contrast.

          -  Left ejection fraction determined by echocardiogram and/or multiple gated acquisition
             (MUGA) technique within 12 weeks of registration;

          -  Zubrod Performance Status 0-1;

          -  Age > 18;

          -  Adequate bone marrow function, defined as follows:

          -  Absolute neutrophil count (ANC) > 1,800 cells/mm3 based upon CBC/differential obtained
             within 2 weeks prior to registration on study;

          -  Platelets > 100,000 cells/mm3 based upon complete blood count (CBC)/differential
             obtained within 2 weeks prior to registration on study;

          -  Hemoglobin > 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to
             registration on study (Note: The use of transfusion or other intervention to achieve
             Hgb > 8.0 g/dl is acceptable.)

          -  Adequate hepatic function, defined as follows:

          -  Bilirubin < 1.5 mg/dl within 2 weeks prior to registration on study; For patients with
             Gilbert's disease as the sole cause of elevated bilirubin, please contact the PI, Dr.
             Ang.

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2x the upper
             limit of normal within 2 weeks prior to registration on study;

          -  Adequate renal function, defined as follows:

          -  Serum creatinine < 1.5 mg/dl within 2 weeks prior to registration

          -  Creatinine clearance (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined
             by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age)
             x (wt in kg)]/[(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male)

          -  Pregnancy test within 2 weeks prior to registration for women of childbearing
             potential;

          -  Women of childbearing potential and male participants must agree to use a medically
             effective means of birth control throughout their participation in the treatment phase
             of the study (until at least 60 days following the last study treatment);

          -  Patient must sign study specific informed consent prior to study entry.

        Exclusion criteria:

          -  Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
             for a minimum of 3 years;

          -  Patients with simultaneous primaries or bilateral tumors are excluded.

          -  Gross total excision (e.g., by tonsillectomy) of the primary tumor; however, partial
             removal of the tumor to alleviate an impending airway obstruction does not make the
             patient ineligible.

          -  Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
             different cancer is allowable;

          -  Prior radiotherapy to the region of the study cancer that would result in overlap of
             radiation therapy fields;

          -  Primary site of tumor of oral cavity, nasopharynx, sinuses, or salivary glands;

          -  Initial surgical treatment, excluding diagnostic biopsy of the primary site or nodal
             sampling of neck disease; radical or modified neck dissection is not permitted.

          -  Severe, active co-morbidity, defined as follows:

          -  Current 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;

          -  Left Ventricular Ejection Fraction < 45%;

          -  Transmural myocardial infarction within the last 6 months;

          -  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 at the time of registration;

          -  Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease
             Control and Prevention (CDC) definition; note, however, that HIV testing is not
             required for entry into this protocol. The need to exclude patients with AIDS from
             this protocol is necessary because the treatments involved in this protocol may be
             significantly immunosuppressive. Protocol-specific requirements may also exclude
             immuno-compromised patients.

          -  Any uncontrolled condition, which in the opinion of the investigator, would interfere
             in the safe and timely completion of study procedures;

          -  CTCAE, v. 3.0 grade 3-4 electrolyte abnormalities:

               -  Calcium < 7 mg/dl or > 12.5 mg/dl;

               -  Glucose < 40 mg/dl or > 250 mg/dl;

               -  Magnesium < 0.9 mg/dl or > 3 mg/dl;

               -  Potassium < 3 mmol/L or > 6 mmol/L;

               -  Sodium < 130 mmol/L or > 155 mmol/L

          -  Pregnant or lactating women or women of childbearing potential and men who are
             sexually active and not willing/able to use medically acceptable forms of
             contraception; this exclusion is necessary because the treatment involved in this
             study may be significantly teratogenic.

          -  Prior allergic reaction to the study drug(s) involved in this protocol;

          -  Prior therapy that specifically and directly targets the EGFR pathway;

          -  Prior severe infusion reaction to a monoclonal antibody.