Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer Erlotinib RADPLAT
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 21
Healthy volunteers: no

Brief 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

Detailed description:
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).

Arms:
arm 1: All patients will receive RADPLAT and Tarceva:

Drug: Erlotinib (Tarceva)

150 mg daily X 7 weeks

Other Names:

Tarceva

Drug: Intra-arterial Cisplatin (PLAT)

1 dose (150 mg/sq) per week X 4 weeks

Other Names:

Cisplatin

Radiation: Radiation Therapy (RAD)

5 days per week X 7 weeks

Interventions: intervention 1: Erlotinib (Tarceva) intervention 2: Intra-arterial Cisplatin (PLAT) intervention 3: Radiation Therapy (RAD)
Intervention descriptions: intervention 1: 150 mg daily X 7 weeks intervention 2: 1 dose (150 mg/sq) per week X 4 weeks intervention 3: 5 days per week X 7 weeks

Protocol document: