Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Condition: Stage III Squamous Cell Carcinoma of the Hypopharynx; Stage III Squamous Cell Carcinoma of the Larynx; Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage III Squamous Cell Carcinoma of the Nasopharynx; Stage III Squamous Cell Carcinoma of the Oropharynx; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IV Squamous Cell Carcinoma of the Oropharynx
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Laryngeal Neoplasms; Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Nasopharyngeal Carcinoma; Laryngeal Diseases
Intervention: erlotinib hydrochloride; cisplatin; 3-dimensional conformal radiation therapy; intensity-modulated radiation therapy; quality-of-life assessment
Intervention description: Given orally; Given IV; 35 fractions; 35 fractions; Ancillary studies
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial is studying cisplatin and radiation therapy together with or
      without erlotinib hydrochloride to compare how well they work in treating patients with stage
      III or stage IV head and neck cancer. Drugs used in chemotherapy, such as cisplatin, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Specialized radiation therapy that delivers a high dose of radiation
      directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
      Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. It may also make tumor cells more sensitive to radiation therapy.
      Giving cisplatin and radiation therapy together with erlotinib hydrochloride may kill more
      tumor cells. It is not yet known whether cisplatin and radiation therapy are more effective
      with or without erlotinib hydrochloride in treating head and neck cancer
    

Eligibility criteria:

        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