| Exclusion Criteria: | 1) Patients who have had docetaxel in nonradiosensitizing therapy
2) Patients who have received prior full dose systemic chemotherapy for NSCLC (ie neoadjuvant, adjuvant, or metastatic) within the last 6 months.
3) ECOG status of 2 or greater
4) Screening clinical laboratory values:*ANC of <1,500/µL *Platelet count of <75,000/µL * INR >/= 1.5 *T bilirubin elevation above normal (MDACC upper normal limit is 1.0 mg/dL) *Serum creatinine of >2.0 mg/dL *Hemoglobin of <9 mg/dL (may be transfused or receive epoetin alfa [e.g., Epogen®] to maintain or exceed this level) *The pt is ineligible if: 1.alk phos>5xULN; 2.AST or ALT >5xULN; 3.alk phos >1xULN but </= 2.5xULN AND AST or ALT >1.5xULN but </=5xULN;4.alk phos >2.5xULN but </=5xULN AND AST or ALT > 1xULN but</= 1.5xULN; 5.alk phos >2.5xULN but</=5xULN AND AST or ALT >1.5xULN but </=5xULN
5) Inability to comply with study and/or follow-up procedures
6) History of other disease, active infection, metabolic dysfunction , physical examination finding, or clinical laboratory finding which is uncontrolled requiring medical intervention giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
7) Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a bevacizumab cancer study
8) Prior exposure to anti-VEGF therapy
9) Blood pressure of > 140/90 mmHg as documented in two consecutive blood pressure readings within 4 hours
10) Any prior history of hypertensive crisis or hypertensive encephalopathy
11) New York Heart Association (NYHA) Grade II or greater congestive heart failure
12) History of myocardial infarction or unstable angina within 6 months
13) History of stroke or transient ischemic attack within 6 months
14) Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
15) Evidence of bleeding diathesis or coagulopathy
16) Presence of central nervous system or brain metastases at any time
17) Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
18) Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
19) Pregnant (positive pregnancy test) or lactating
20) Proteinuria at screening as demonstrated by either: Urine protein:creatinine (UPC) ratio > 1.0 at screening OR Urine dipstick for proteinuria > 2+ (patients discovered to have > 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate < 1g of protein in 24 hours to be eligible).
21) History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
22) Serious, non-healing wound, ulcer, or bone fracture
23) Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, cavitation.
24) History of hemoptysis (bright red blood of 1/2 teaspoon or more)
25) Full dose anitcoagulation, chronic use of Aspirin (>325 mg/day) or NSAIDs
26) Inability to comply with study and/or follow-up procedures |