Safety and Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMAb VEGF and EGFR Tyrosine Kinase Inhibitor OSI-774 for Locally Advanced or Metastatic Non-Squamous Cell NSCLC in Patients Who Have Been Previously Treated
- 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 >=
- 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
- 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
- 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)