A Phase II Study of Bevacizumab Plus Docetaxel and Gemcitabine in Subjects With Advanced, Previously Untreated, Non-Squamous Non-Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed non-squamous cell non-small cell lung cancer

- Stage IIIB (with pleural effusion), stage IV, or recurrent disease

- Bidimensionally measurable disease

- No known CNS disease, except for previously treated brain metastasis defined as no
evidence of progression or hemorrhage after treatment AND no ongoing requirement for
dexamethasone as documented by clinical examination, MRI, or CT scan

- Treatment for brain metastases may have included whole brain radiotherapy,
radiosurgery (gamma knife, LINAC, or equivalent), or a combination of therapy as
deemed appropriate by the treating physician

- Stable dose of anticonvulsants allowed

- No known metastatic disease to the gastrointestinal tract (e.g., stomach, small
bowel, or large bowel)

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Life expectancy > 3 months

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Bilirubin ≤ 2.0 mg/dL

- AST or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if hepatic
metastases are present)

- Serum creatinine ≤ 1.8 mg/dL

- Urine protein:creatinine ratio < 1.0 OR proteinuria < 2+ by urine dipstick OR ≤ 1 g
of protein by 24-hour urine collection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Available for regular follow-ups

- No inadequately controlled hypertension, defined as systolic BP > 150 mm Hg and/or
diastolic BP > 100 mm Hg despite antihypertensive medications

- No history of hypertensive crisis or hypertensive encephalopathy

- No NYHA class II-IV congestive heart failure

- No myocardial infarction or unstable angina within the past 6 months

- No stroke or transient ischemic attack within the past 6 months

- No significant vascular disease (e.g., aortic aneurysm, aortic dissection requiring
surgical repair, or recent peripheral arterial thrombosis) within the past 6 months

- No symptomatic peripheral vascular disease

- No evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic
anticoagulation)

- No history of colonic diverticular disease (i.e., diverticulosis or diverticulitis)

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months

- No serious, nonhealing wound, ulcer, or bone fracture

- No known hypersensitivity to any component of bevacizumab

- No hemoptysis (bright red blood of ≥ ½ teaspoon per episode) within the past 3 months

- No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy or biological therapy

- No prior radiotherapy to an area of measurable disease unless there is documented
progressive disease after completion of therapy

- More than 2 weeks since prior radiotherapy

- More than 4 weeks since prior and no concurrent participation in another experimental
drug study, except for a Genentech-sponsored bevacizumab cancer study

- More than 28 days since prior major surgical procedure or open biopsy

- More than 3 months since prior abdominal surgery

- More than 3 months since prior neurosurgical resection or brain biopsy

- More than 7 days since prior core biopsy or other minor surgical procedure, except
placement of a vascular access device

- No concurrent major surgical procedure