Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed solid tumor meeting 1 of the following criteria:

  • KRAS wild-type colorectal cancer
  • Squamous cell head and neck cancer
• Metastatic or unresectable disease for which standard curative or palliative measures do not exist or are no longer effective

• Patients with colorectal cancer must be resistant or refractory to cetuximab or panitumumab (expansion cohort)

  • Progressive disease during cetuximab or panitumumab therapy or within 3 months after cetuximab or panitumumab therapy

• No uncontrolled brain metastases

  • Patients who have received definitive therapy, including radiotherapy, and are not requiring ongoing medical therapy (i.e., steroids) for brain metastases allowed
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky > 60%)
• Life expectancy > 3 months
• Leukocytes > 3,000/mcL
• Absolute neutrophil count (ANC) > 1,500/mcL
• Platelet count > 100,000/mcL
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamci oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) < 2.5 x institutional upper limit of normal (ULN)
• Creatinine clearance > 60 mL/min/1.73m^2 as calculated using modified Cockcroft-Gault formula
• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to starting Cycle 1 of lenalidomide. Further, they 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 starting 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; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure
• Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
• All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
• Able to take aspirin (81 or 325 mg) daily for prophylactic anticoagulation

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (>= grade 3) due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents
• Uncontrolled brain metastases; patients who have received definitive therapy, including radiation, and are not requiring ongoing medical therapy (i.e. steroids) for brain metastases will be allowed
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide or cetuximab or other agents used in study
• Patients with a recent history of deep vein thrombosis (DVT)/pulmonary embolism (PE) requiring therapy (within 3 months)
• Patients with history of toxicity >= grade 3 with prior EGFR directed therapy
• Patient with confirmed history of interstitial lung disease
• Uncontrolled concurrent 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 lenalidomide is Food and Drug Administration (FDA) pregnancy category X agent with the potential for teratogenic or abortifacient effects; cetuximab is FDA pregnancy category C; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lenalidomide or cetuximab, breastfeeding should be discontinued if the mother is treated with either agent; these potential risks may also apply to other agents used in this study
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated