Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
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
Head and neck malignancies represent a group of epidermoid tumors that arise from the
 epithelial lining of the mouth, pharynx, and larynx. Three modalities of therapy have
 established roles in the treatment of carcinoma of the head and neck: chemotherapy, radiation
 therapy (XRT), and surgery. The choice of modality depends upon many factors such as the site
 and extent of the primary lesion, the likelihood of complete surgical resection, the presence
 of lymph node metastases, etc. Traditionally, smaller lesions (stage T1-T2) are effectively
 treated either, by surgical excision or irradiation whereas more advanced disease (stage
 III-IV) is treated with combined surgery and XRT. The subsequent morbidity related to
 extensive surgery is a major problem among survivors. Clearly, there is a need to develop
 therapeutic strategies for patients with advanced head and neck cancer with more effective
 approaches employing non-surgical modalities.

 Our hypothesis is that head and neck cancers are resistant to apoptosis from DNA damage
 induced by radiation and chemotherapy. This resistance is mediated by EGFR overexpression
 which results in downstream activation of cell survival signals, such as AKT, and may be
 overcome when Erlotinib (Tarceva) is co-administered with RADiation and cisPLATin
 (intraarterial chemotherapy).
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).