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 longer likely 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 upper limit 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 after completion 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 the treatment of cancer)

Exclusion Criteria:

• Untreated or symptomatic central nervous system (CNS) metastases
• Concurrent serious systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient'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 study treatment