Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors

Inclusion Criteria:

• Diagnosis of solid tumor that overexpresses epidermal growth factor receptor (EGFR)including, but not limited to, the following:

• Breast cancer

• Lung cancer

• Colon cancer

• Pancreatic cancer

• Head and neck cancer

• Kidney cancer

• Sarcoma

• Advanced disease

• Must have failed or become intolerant to prior standard therapy and is no longerlikely to respond to such therapy

• Measurable or nonmeasurable disease

• ECOG performance status 0-1

• ANC ≥ 1,500/mm³

• Platelet count > 100,000/mm³

• Hemoglobin > 9 g/dL

• Bilirubin < 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase < 3.0 times ULN (5.0 times ULN if liver has tumor involvement)

• Aspartate aminotransferase (AST) and alanine aminotransferase (*ALT) < 3.0 times upperlimit of normal (ULN) (5.0 times ULN if liver has tumor involvement)

• Creatinine clearance > 30 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months aftercompletion of study treatment

• Recovered from all prior therapy

• Prior systemic chemotherapy, immunotherapy, or biological therapy allowed

• At least 14 days since prior radiotherapy or systemic therapy

• At least 30 days since prior investigational agents

• At least 14 days since other prior investigational drugs (for reasons other than thetreatment of cancer)

Exclusion Criteria:

• Untreated or symptomatic central nervous system (CNS) metastases

• Concurrent serious systemic disorders (e.g., active infection) that, in the opinion ofthe investigator, would compromise the safety of the patient or compromise thepatient's ability to complete the study

• Uncontrolled diabetes

• Myocardial infarction within the past 6 months

• New York Heart Association (NYHA) class III or IV heart failure

• Uncontrolled angina

• Severe uncontrolled ventricular arrhythmias

• Evidence of acute ischemia or active conduction system abnormalities by ECG

• Peripheral neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade > 2

• Known hypersensitivity to bortezomib, boron, or mannitol

• Serious medical or psychiatric illness likely to interfere with study participation

• Prior bortezomib and/or cetuximab

• Concurrent filgrastim (G-CSF) or other hematologic support during course 1 of studytreatment