Volociximab and Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
• Failed ≥ 1 prior chemotherapy regimen OR refused first-line therapy
• Measurable disease

• No active and untreated CNS tumor or metastasis

  • Previously treated CNS tumor(s) allowed if CT scan or MRI shows clear-cut response or resolution of the original lesion(s)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Hemoglobin ≥ 9.0 g/dL
• WBC ≥ 2,500/mm^3
• Absolute neutrophil count ≥ 1,000/mm^3 (growth factor independent)
• Platelet count ≥ 100,000/mm^3
• Total bilirubin ≤ 1.5 mg/dL
• AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if patient has liver metastases)
• Alkaline phosphatase ≤ 5 times ULN
• Serum creatinine ≤ 2.0 mg/dL
• PT/PTT normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective (double barrier or abstinence) contraception
• No uncontrolled seizure disorder or active neurological disease
• No thromboembolic events (i.e., stroke or deep vein thrombosis) within the past year

• No clinically significant medical condition that would complicate compliance with study treatment or be exacerbated by bleeding, including but not limited to:

  • Known bleeding disorders, such as coagulation defects and thrombasthenias
  • Active gastric or duodenal ulcer
  • History of gastrointestinal (GI) bleeding requiring transfusion within the past year
  • History of tumor bleeding
  • History of significant hemoptysis requiring intervention (i.e., transfusion, laser therapy, surgical treatment, or radiation) within the past year
• No known active infections requiring IV antibiotics, antivirals, or antifungals (e.g., HIV, hepatitis B, or hepatitis C infection)

• No unstable cardiac disease, including any of the following:

  • Poorly controlled angina
  • Congestive heart failure
  • Arrhythmias
  • Myocardial infarction within the past year
  • Acute ischemia by ECG

  • Untreated significant conduction abnormality

    • Bifascicular block (defined as left anterior hemiblock in the presence of right bundle branch block)
    • Second- or third-degree atrioventricular block
• No asthma or oxygen-dependent chronic pulmonary disease
• No cerebrovascular event (e.g., stroke or transient ischemic attack) within the past year
• No peripheral vascular disease requiring surgery within the past year

• No clinically significant or unstable medical condition, including, but not limited to, any of the following:

  • Diabetes mellitus requiring insulin
  • Uncontrolled hypertension
  • Uncontrolled or symptomatic orthostatic hypertension
• No serious psychiatric illness, active alcoholism, or drug addiction that may preclude study treatment
• No condition that, in the investigator's opinion, would make the patient unsuitable for study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Prior immunotherapy, including monoclonal antibodies, or vaccine therapy allowed

• No systemic biologic, immunotherapy, or radiation therapy within the past 4 weeks

  • Local radiotherapy to a single site of bone metastasis within the past 2 weeks allowed provided patient has recovered from any side effects
• No prior volociximab, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors, or inhibitors of α5β1 integrin (antibodies or small molecules)
• No known hypersensitivity to murine proteins or chimeric antibodies or other components of study drugs
• No other investigational drug within the past 4 weeks or 5 half-lives (whichever is longer)
• No monoclonal antibody therapy within the past 4 weeks or 5 half-lives (whichever is longer)
• No major surgery (e.g., thoracotomy) within 4 weeks prior to study entry
• No minor surgery (e.g., central venous line placement) within 1 week prior to study entry
• No sargramostim (GM-CSF) or filgrastim (G-CSF) within the past 7 days
• No prior bone marrow or stem cell transplantation

• No concurrent chronic medications that would interfere with study drug assessment including, but not limited to:

  • High-dose glucocorticoids (prednisone ≥ 20 mg/day or equivalent)

  • Chronic nonsteroidal anti-inflammatory drugs (NSAIDs)

    • Infrequent or as occasion requires use of NSAIDs allowed

• No concurrent high-dose aspirin (> 81 mg/day), high-dose warfarin, or heparin

  • Aspirin ≤ 81 mg/day, low-dose warfarin (1 mg/day), or low-dose heparin for IV-catheter patency allowed
• No concurrent chemotherapy, therapeutic radiation, or anticancer hormonal therapy
• No other concurrent immunotherapy
• No other concurrent potentially antiangiogenic therapy (e.g., cyclo-oxygenase-2 inhibitors, thalidomide, or tretinoin)