Phase I/II Study of Postoperative Adjuvant Chemoradiation for Advanced-Stage Cutaneous Squamous Cell Carcinoma of the Head and Neck (cSCCHN)

This is an interventional treatment trial for Recurrent Skin Cancer Read More

Inclusion Criteria:

• Patients must have primary or recurrent advanced-stage (III/IV) squamous cell carcinoma of the skin of the face, ear, scalp or neck or of the lip
• A biopsy or preserved representative tumor block is required to confirm the diagnosis
• Patients must be surgical candidates with resectable disease; macroscopic complete resection of all tumor must be planned with curative intent
• Patients must be willing to receive postoperative radiation therapy and treatment with study drugs
• Both men and women and members of all races and ethnic groups will be included
• Life expectancy of greater than 12 months
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Absolute neutrophil count >= 1,500/microliter(uL)
• Hemoglobin >= 9 g/dL
• Platelets >= 100,000/uL
• International normalized ratio (INR) < institutional upper limit of normal (ULN)
• Total bilirubin =< 1.5 x institutional ULN
• Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) =< 2.5 X institutional ULN
• Creatinine =< 1.5 X institutional ULN
• Fasting blood glucose < 125 mg/dL at baseline
• Patients-both males and females-with reproductive potential (i.e., menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study; women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Patients with known distant metastasis
• Patients who have had prior radiation treatment of the index cancer or area of disease
• Patients who have received any other investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study
• Prior treatment with EGFR inhibitor for index cancer
• Prior treatment with an IGF-1R antagonist (small molecule inhibitor or antibody)
• Breast-feeding, pregnancy or of childbearing potential (including less than two years postmenopausal) and unable to confirm adequate contraception due to possible risk to fetus or infant
• Insulin-dependent and non-insulin dependent diabetes mellitus including any metformin or insulin use on an ongoing basis prior to enrollment
• Known severe hypersensitivity to erlotinib, other small molecule inhibitors of EGFR, or its excipients
• Hepatitis B or C infection (acute or chronic), known human immunodeficiency virus (HIV), or active uncontrolled infection, because of possible risk of lethal infection when treated with marrow suppressive therapy
• History of uncontrolled cardiac disease such as unstable angina pectoris, myocardial infarction within prior 6 months, untreated coronary artery disease, uncontrolled congestive heart failure, or cardiomyopathy with decreased ejection fraction
• Uncontrolled peptic or gastric ulcer disease or gastrointestinal bleeding within prior 6 months
• Corrected QT interval (QTc) > 450 msec; congenital long QT syndrome or previous history of QTc prolongation as a result from other medication
• Presence of left bundle branch block (LBBB); QTc with Bazett's correction that is unmeasurable, or >= 450 msec on screening electrocardiogram (EKG)
• Any concomitant medication that may cause QTc prolongation or concomitant medication that is associated with Torsades de Pointes
• Psychiatric illness/social situations that would limit compliance with study requirements
• Active smokers unwilling to quit smoking during treatment
• Use of the potent cytochrome P450 3A4 (CYP3A4) and cytochrome P450 1A2 (CYP1A2) inhibitors is not allowed; other less potent CYP3A4 and CYP1A2 inhibitors/inducers are not excluded
• Participation in another investigational trial while on this study is not allowed
• History of poorly controlled gastrointestinal disorders including acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, Crohn's disease, ulcerative colitis or other diseases which have the potential for bowel perforation
• Other malignancies except for resected cervical cancer in situ