Carboplatin, Pemetrexed Disodium, and Bevacizumab for Patients With Stage III or IV Non-Small Cell Lung Cancer Who Are Light/Never Smokers

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer Read More

DISEASE CHARACTERISTICS:

• Histologically confirmed primary lung carcinoma

  • Non-squamous histology
  • Advanced disease defined as stage IIIB disease with cytologically documented malignant pleural or pericardial effusion or stage IV disease

• Available pathology block or unstained slides from initial or subsequent diagnosis

  • Must have undergone ≥ 1 core biopsy
  • No patients whose diagnosis was made through a fine-needle aspirate
• No uncontrolled pleural effusions, ascites, or third-space fluid collections

• Meets 1 of the following criteria:

  • Non-smoker, defined as patients who smoked ≤ 100 cigarettes in their lifetime
  • Former light smoker, defined as patients who smoked between > 100 cigarettes AND ≤ 10 pack-years AND quit ≥ 1 year ago

• No known central nervous system disease, except for treated brain metastases meeting the following criteria:

  • No evidence of progression or hemorrhage after treatment
  • No ongoing requirement for dexamethasone as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period
  • Stable doses of anticonvulsants are allowed
  • Treatment for brain metastases may include whole-brain radiotherapy, radiosurgery (gamma knife, LINAC, or equivalent), or a combination as deemed appropriate by the treating physician
  • No patients with central nervous system (CNS) metastases treated by neurosurgical resection
  • No brain biopsy within the past 3 months

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Absolute neutrophil count (ANC) ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST/ALT) ≤ 2.5 times ULN
• Calculated creatinine clearance > 45 mL/min OR creatinine ≤ 1.5 times ULN
• Prothrombin time ≤ 1.5 times ULN
• Partial thromboplastin time ≤ ULN
• Urine protein:creatinine ratio ≤ 1.0
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

• Patients with a history of hypertension are eligible provided it is well controlled (BP < 150/100 mm Hg) on a stable regimen of antihypertensive therapy

  • No history of hypertensive crisis or hypertensive encephalopathy
• Able and compliant with folic acid and B12 supplementation
• Able to swallow tablets intact or dissolved in water
• No dysphagia or active gastrointestinal (GI) disease or disorder that alters GI motility or absorption
• No lack of integrity of the GI tract (e.g., a significant surgical resection of the stomach or small bowel)
• No abdominal fistula, GI perforation, or intraabdominal abscess within the past 6 months

• None of the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure (NYHA class II-IV)
  • Cardiac arrhythmia
  • Psychiatric illness, social situations, or any other medical condition that would limit compliance with study requirements
• No myocardial infarction or other evidence of arterial thrombotic disease (angina) within the past 6 months
• No history of cerebral vascular accident or transient ischemic attack within the past 6 months
• No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within the past 6 months
• No history of bleeding diathesis or coagulopathy

• No ongoing hemoptysis, defined as ≥ ½ teaspoon of bright red blood

  • Patients with procedure-related hemoptysis that has resolved post-procedure are eligible
• No serious nonhealing wound, ulcer, bone fracture, or significant traumatic injury within the past 28 days
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy

  • Patient must be chemotherapy naive
  • Prior neoadjuvant or adjuvant chemotherapy allowed provided it was completed ≥ 6 months ago
• No prior anti-vascular endothelial growth factor therapy
• At least 3 weeks since prior major surgery
• At least 1 week since prior radiotherapy
• More than 28 days since prior and no concurrent treatment with an investigational agent
• More than 7 days since prior core biopsy
• Concurrent daily treatment with aspirin or NSAIDs are eligible provided patients are able to interrupt NSAIDs 2 days before (5 days for long-acting NSAIDs), the day of, and for 2 days following the administration of pemetrexed disodium
• No concurrent treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), and/or cilostazol (Pletal)