The links after "Participants" show which Southwest Oncology Group institutions are eligible to participate in this study.

The orange "Where is This Study Open?" tab at the bottom of the page shows the institutions whose Institutional Review Boards (IRBs) have approved the protocol so that it can be opened at that institution. Clicking on the Institution Name will show the points of contact for information about this study at that institution.

Disease Committee: Lung Cancer

Participants: Members, CCOP, Affiliates, Medical Oncologists

Eligibility Criteria: Pts must have histologic or cytologically confirmed NSCLC, adeno, large cell, or unspecified, Stage IIIB with pleural effusion or IV, advanced or recurrent after previous surgery and/or irradiation. Pts must not have tumors with > 50% squamous cell carcinoma components. No Prior systemic chemo, adjuvant, or bio therapy for NSCLC. No symptomatic neuropathy-sensory > Grade 2. No other prior malignancy except: treated basal cell or squamous cell skin ca, in situ cervical, Stage I or II ca in complete remission; disease-free from any ca for 5 years. Pts must have measurable or non-measurable disease by CT. Pleural effusion, ascites and lab parameters are not acceptable as the only evidence of disease. Pts may have prior radiation > 3wks since completion and must be recovered from tox at registration. Pts must not have: history (w/i 6 months) of CVA, MI, unstable angina, uncontrolled HTN, CHF > Grade 2 (NY Heart Ass.), serious cardiac arrhythmia requiring medication, clinically significant PVD. Pts must not have: Open bx or significant traumatic injury w/i 28 days, core bx w/i 7 days; non healing wound; ulcer or bone fx; h/o abdominal fistula; GI perforation or intra-abdominal abscess w/i 28 days; evidence of bleeding diathesis or coagulopathy; acute hepatitis or active or uncontrolled infection. Pts must have UPC <0.5, or if > 0.5; 24 hr urine protein <1000mg; serum creat < IULN AND calc/meas creat clear > 50cc/min. Pts must have adequate hepatic function: bili, SGOT or SGPT and alk phos <2 x IULN; adequate renal function: serum creat < IULN AND calc or measured creat clearance > 50 ml/min. (See formula Section 5.9) ANC>1,5000 and platelet >100,000. For GMP: Hgb > 9 mg/dl. No prior treatment with cetuximab, erlotinib, ZD1839 (gefitinib), or other agents that target the EGFR pathway. No treatment w/VEGF-related agents. Pts may not have received prior chimerized or murine monoclonal antibody therapy or have presence of human anti-mouse antibodies (HAMA). No known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies. Pts must have INR < 1.5 if not on full dose anticoagulation. No active bleeding or pathologic condition that carries a high risk of bleeding. Pts may be on low-dose warfarin. No brain mets. Pts must have recovered from sx at least 4 wks prior. No pregnant or nursing women. Pts must have PS 0-1, 18 years or older, willing to submit prior smoking history. Pts must not be on full-dose anticoagulation.