Cetuximab and Lenalidomide in Head and Neck

Inclusion Criteria

• •1. Understand and voluntarily sign an informed consent form.
• •2. Age ≥18 years at the time of signing the informed consent form.
• •3. Able to adhere to the study visit schedule and other protocol requirements.
• •4. Recurrent or metastatic squamous cell or undifferentiated carcinoma of the head and neck that is not amenable to curative therapy. Patients who are candidates for local or locoregional therapy should not be deprived of proven beneficial palliative therapies.
• •5. All previous cancer therapy, including radiation, hormonal therapy, EGFR inhibitors, and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
• •6. ECOG performance status of 0-1 at study entry.
• •7. Laboratory test results within these ranges:
• •* Absolute neutrophil count to ≥ 1000/mm³
• •* Platelet count ≥ 100,000/mm³
• •* Calculated creatinine clearance ≥ 50ml/min by Cockcroft-Gault estimation
• •* Total bilirubin \< 1.5 x ULN
• •* AST (SGOT) and ALT (SGPT) \< 3 x ULN or \< 5 x ULN if hepatic metastases are present.
• •9. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
• •10. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
• •11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
• •12. Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded), with minimum lesion size ≥ 2 cm on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan. Lesions that can be measured clinically must be at least 1 cm in greatest dimension by caliper measurement.