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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients must have histologically or cytologically confirmed malignancy that is
metastatic or unresectable and for which standard curative or palliative measures do
not exist or are no longer effective; eligible malignancies include: colorectal cancer
KRAS wild-type and squamous cell head and neck cancer
- No curative intent therapy available; there is no limit on prior number of therapies;
prior epidermal growth factor receptor (EGFR)-directed therapy (tyrosine kinase
inhibitors and monoclonal antibodies - including cetuximab, panitumumab, or
investigational EGFR directed monoclonal antibodies) will be allowed in the phase I
dose escalation; patients who have received monoclonal antibody therapy must be off
all monoclonal antibodies four weeks (28 days) prior to study treatment; no
chemotherapy within 28 days of trial medication
- There will be an expansion cohort for colorectal cancer patients only; for the
expansion cohort, there is no limit on prior chemotherapy; the colorectal expansion
cohort will include patients with cetuximab or panitumumab-resistant or refractory
disease (progression during cetuximab/panitumumab therapy or within 3 months of
cetuximab/panitumumab therapy
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky > 60%)
- Life expectancy of greater than 3 months
- Leukocytes > 3,000/mcL
- Absolute neutrophil count > 1,500/mcL
- Platelets > 100,000/mcL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
< 2.5 x institutional upper limit of normal
- Creatinine clearance > 60 mL/min/1.73 m^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 (patients
intolerant to aspirin may use warfarin or low molecular weight heparin)
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; breastfeeding should be discontinued if
the mother is treated with either agent
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
therapy are ineligible
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
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Recurrent Salivary Gland Carcinoma
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Salivary Gland Squamous Cell Carcinoma
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Stage IVB Rectal Cancer AJCC v7
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Recurrent Oropharyngeal Squamous Cell Carcinoma
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Stage IVA Laryngeal Verrucous Carcinoma AJCC v7
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Stage IVB Colon Cancer AJCC v7
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Stage IVB Oral Cavity Cancer AJCC v6 and v7
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Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7
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Stage IVC Laryngeal Verrucous Carcinoma AJCC v7
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Recurrent Laryngeal Squamous Cell Carcinoma
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Recurrent Laryngeal Verrucous Carcinoma
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Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary
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Stage IVA Colon Cancer AJCC v7
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Stage IVA Major Salivary Gland Cancer AJCC v7
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Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
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Stage IVC Major Salivary Gland Cancer AJCC v7
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Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7
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Tongue Carcinoma
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Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma
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Stage IVA Oral Cavity Cancer AJCC v6 and v7
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Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
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Recurrent Oral Cavity Verrucous Carcinoma
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Stage IVA Rectal Cancer AJCC v7
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Stage IVB Laryngeal Verrucous Carcinoma AJCC v7
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Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7
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Recurrent Colon Carcinoma
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Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
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Recurrent Hypopharyngeal Squamous Cell Carcinoma
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Recurrent Rectal Carcinoma
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Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary
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Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
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Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
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Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
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Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
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Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7
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Stage IVB Major Salivary Gland Cancer AJCC v7
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Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7
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Stage IVC Oral Cavity Cancer AJCC v6 and v7
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Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
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Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7
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Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
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