Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Non-Small Cell Lung Cancer, NSCLC, Lung Cancer, Avastin, Bevacizumab, rhuMAb VEGF, Anti-VEGF monoclonal antibody, Tarceva, OSI-774, Erlotinib Hydrocholoride
Eligibility Criteria
Inclusion Criteria: Patient has histologically proven stage IIIB with pleural effusion, stage IV or recurrent non-squamous NSCLC. Patient has a Karnofsky performance status >=70%. Patient has adequate bone marrow function: WBC >= 3,000 cells/mm3, ANC >= 1,500 cells/mm3, platelet count >= 100,000 cells/mm3, Hgb >= 9.0 g/dL. Patient has adequate liver function: total bilirubin level <= 2.0 mg/dL, albumin >= 2.5 g/dL. Transaminases (aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT)) and alkaline phosphatase may be up to 2.5 x ULN. Patient has adequate renal function: a serum creatinine < 2 mg/dl Patient has signed a written informed consent. Patient has received at least one prior chemotherapeutic regimen for recurrent or metastatic disease. Exclusion Criteria: Patient has not received prior chemotherapeutic regimens for advanced disease. Patient has received prior biologic therapy targeting epidermal growth factor receptor (EGFR) and/or Vascular endothelial growth factor (VEGF). Patient has received radiation therapy within the past 3 weeks. Patient has signs or symptoms of acute infection requiring systemic therapy. Patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent. Patient requires total parenteral nutrition with lipids. Patient has a history of uncontrolled heart disease and/or uncontrolled hypertension (> 150/100 mmHg). Because of the possible teratogenic effect, pregnant women and women who are currently breast-feeding may not participate in this study. - All women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrolling in the study. Serious infection or other intercurrent illness requiring immediate therapy. Clinical/imaging evidence of Central Nervous System (CNS) malignancy or with recently treated CNS malignancy, as well as those experiencing recent cerebrovascular accident (CVA), or other CNS bleeding. Pediatric patients in whom open growth plates would be expected. Urine protein qualitative value of > 30 in urinalysis or > +1 in proteinuria testing by dipstick. Patient has a clinical history of coagulopathy or thrombosis. Patient is currently receiving or intending to receive anti-coagulants. Patient has had a recent myocardial infarction (still inside the healing period). Note: a six-month window is optimal. Patient is recovering from recent major surgery (e.g., less than 2 weeks since surgery) or is anticipating major surgery. Patient has a clinical history of hemoptysis or hematemesis. Patient may not have percutaneous endoscopic gastrostomy (PEG) or gastrostomy (G) tube.
Sites / Locations
- Vanderbilt-Ingram Cancer Center
- University of Texas M.D. Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Avastin + Tarceva
Combination Therapy (Avastin + Tarceva) = Avastin IV Day 1 of each 21-day cycle + oral Tarceva daily.