A Phase II Study of Cisplatin Plus Etoposide (PE) Plus Bevacizumab (NSC #704865) for Previously Untreated Extensive Stage Small Cell Lung Cancer

Inclusion Criteria

Inclusion Criteria

- Histologically or cytologically confirmed small cell lung cancer, staged as extensive
disease

- Measurable disease per RECIST criteria

- Previously irradiated lesions must not be the sole site of measurable disease

- Age 18 and over

- ECOG Performance status 0-2

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- No history of hemorrhagic disorders

- Bilirubin ≤ 1.5 mg/dL

- PTT ≤ upper limit of normal

- INR ≤ 1.5

- Creatinine ≤ 1.5 mg/dL

- Proteinuria < 1+. For proteinuria ≥ 1+, urine protein must be ≤ 1 g/24 hours

- Hypertension must be well-controlled (≤ 150/85) on a stable regimen of
antihypertensive therapy

- Not pregnant or nursing - patient must have negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
treatment

Exclusion Criteria

- Prior radiotherapy to the site of evaluable disease

- CNS metastases by CT scan or MRI within the past 4 weeks

- Symptomatic congestive heart failure

- Cardiac arrhythmia

- History of thrombotic disorders

- Clinically significant peripheral artery disease

- Arterial thromboembolic event within the past 6 months, including transient ischemic
attack, cerebrovascular accident, unstable angina, or myocardial infarction

- History of gross hemoptysis (i.e., ≥ 1 teaspoon of bright red blood)

- Other malignancy within the past 5 years except cured basal cell or squamous cell
skin cancer or carcinoma in situ of the cervix

- Ongoing or active infection

- Psychiatric illness or social situation that would preclude study compliance

- Serious nonhealing wound, ulcer, or bone fracture

- Prior immunotherapy for lung cancer

- Prior biologic therapy for lung cancer

- Prior chemotherapy for lung cancer

- Concurrent local radiotherapy for pain control or life-threatening situations

- Prior major surgery within 28 days

- Prior minor surgery or needle biopsies within 7 days

- Concurrent chronic daily aspirin (> 325 mg/day)

- Concurrent nonsteroidal anti-inflammatory agents known to inhibit platelet function

- Concurrent therapeutic anticoagulation, but prophylactic anticoagulation of venous
access devices is allowed

- Concurrent treatment with Dipyridamole, Ticlopidine, Clopidogrel, Cilostazol