| Exclusion Criteria: | 1) Diagnosis of squamous-cell lung cancer.
2) Anticipation of need for a major surgical procedure or radiation therapy during the study.
3) Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
4) Prior cumulative cisplatin chemotherapy dose exceeding 300 mg/m^2.
5) History of hypersensitivity to any Trap agents, recombinant proteins, taxanes, platinum compounds, fluoropyrimidines, or polysorbate 80.
6) Known dihydropyrimidine dehydrogenase deficiency.
7) Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, cytokine therapy, or major surgery) of study enrollment.
8) Cumulative radiation therapy to >25% of the total bone marrow.
9) Uncontrolled hypertension, defined as blood pressure >140/90 mm Hg (NCI CTCAE v.3.0 grade >/=2), or systolic blood pressure >160 mm Hg if diastolic blood pressure <90 mm Hg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment.
10) Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade >/=2 peripheral neuropathy, peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
11) History of brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT or MRI scan.
12) Evidence of clinically significant bleeding diathesis or underlying coagulopathy.
13) Active infection, or on antiretroviral therapy for HIV disease.
14) Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
15) Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
16) Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
17) Pregnancy or breastfeeding.
18) Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
19) Subjects who have previously been treated with the investigational product. Prior treatment with docetaxel, cisplatin, or 5-fluorouracil, however, may be permitted.
20) A subject may not be enrolled in this study more than once |