Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: Erlotinib (Tarceva); Intra-arterial Cisplatin (PLAT); Radiation Therapy (RAD)
Intervention description: 150 mg daily X 7 weeks; 1 dose (150 mg/sq) per week X 4 weeks; 5 days per week X 7 weeks
Intervention MeSH terms: Cisplatin; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck Cancer; Erlotinib; RADPLAT

Summary:

      The purpose of this study is to determine the safety and effectiveness of treatment with
      Tarceva (Erlotinib) and RADPLAT (RADiation and intraarterial cisPLATin) for patients with
      Head and Neck cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed Stage III-IV disease
             comprised of T3 or T4 N0-2 lesions of the oral cavity, oropharynx, hypopharynx, and
             larynx.

          -  No previous radiation therapy or chemotherapy.

          -  No evidence of distant metastatic disease.

          -  Age > 18.

          -  Karnofsky performance status of > 60 (ECOG 2).

          -  ANC > 1000, platelets > 100,000, calculated or 24-hour creatinine clearance > 60.

          -  Study-specific informed consent form.

          -  Protocol treatment must begin < 8 weeks of diagnostic biopsy.

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  Patients with surgically cured secondary malignancy who have been disease free > 5
             years are eligible.

        Exclusion Criteria:

          -  Radiologic evidence of bone destruction.

          -  Previous or concurrent head and neck primaries.

          -  Prior surgery to study site other than biopsy.

          -  Patients receiving any other investigational agents.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to agents used in the study.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Pregnant women are excluded from this study because treatments and agents have the
             potential for teratogenic or abortifacient effects. For this reason, women of
             child-bearing potential and men must agree to use adequate contraception (hormonal or
             barrier method of birth control; abstinence) prior to study entry and for the duration
             of study participation. Should a woman become pregnant or suspect she is pregnant
             while participating in this study, she should inform her treating physician
             immediately.

          -  History of a prior or concomitant malignancy (other than carcinoma in situ of the
             cervix, basal cell or squamous cell carcinoma of the skin).