Avastin/Docetaxel/Carboplatin in Non-Small Cell Lung Cancer

Inclusion Criteria

• Men and women, at least 18 years old, with histologically confirmed, advanced stage IIIB or IV NSCLC for whom no curative options exist and for whom docetaxel and carboplatin is a reasonable treatment option;
• At least 1 target lesion that is unidimensionally measurable as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) and has not been previously irradiated;
• Eastern Cooperative Oncology Group Performance Status of 0 or 1, (determined within 2 weeks prior to receiving study medication;
• Ability to understand and adhere to the protocol requirements, and give informed consent
• Use of effective means of contraception (men and women) in subjects of child-bearing potential. Child-bearing potential is defined as follows: A woman of childbearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria

• Patients who have had docetaxel in nonradiosensitizing therapy
• Patients who have received prior full dose systemic chemotherapy for NSCLC (ie neoadjuvant, adjuvant, or metastatic) within the last 6 months.
• Eastern Cooperative Oncology Group (ECOG) status of 2 or greater
• Screening clinical laboratory values: *absolute neutrophil count (ANC) of /= 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 5xULN; 2.AST or ALT >5xULN; 3.alk phos >1xULN but 1.5xULN but 2.5xULN but 1xULN but 2.5xULN but 1.5xULN but 140/90 mmHg as documented in two consecutive blood pressure readings within 4 hours
• Any prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• History of myocardial infarction or unstable angina within 6 months
• History of stroke or transient ischemic attack within 6 months
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
• Evidence of bleeding diathesis or coagulopathy
• Presence of central nervous system or brain metastases at any time
• 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
• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
• Pregnant (positive pregnancy test) or lactating
• 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 325 mg/day) or NSAIDs
• Inability to comply with study and/or follow-up procedures