Volociximab and Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
Eligibility Criteria
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)
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA