Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
• Squamous cell histology allowed
• No mixed histology with small cell component
• Stage IIIB (with pleural effusion) or stage IV disease
• Presence of peritoneal or pericardial effusion alone in the absence of cytologic evidence is not allowed
• Measurable disease, defined as ≥ 1 lesion with longest diameter ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
• If the only site of measurable disease was previously irradiated, progressive disease must be evident
• Ineligible for bevacizumab therapy
• No symptomatic, untreated, or uncontrolled CNS metastases
• CNS metastases treated with whole-brain radiation (WBRT) allowed 4 weeks after completion of WBRT

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Life expectancy ≥ 12 weeks
• Absolute neutrophil count ≥ 1,500/mm^3
• Hemoglobin ≥ 9 g/dL
• Platelet count ≥ 100,000/mm^3
• Bilirubin ≤ 3 times upper limit of normal (ULN)
• ALT and AST ≤ 3 times ULN (5 times ULN if liver involvement)
• Alkaline phosphatase ≤ 5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective nonhormonal contraception
• No proteinuria ≥ 1+
• No uncontrolled blood pressure (BP), defined as systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg in spite of adequate antihypertensive therapy
• No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of AZD2171 (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, malabsorption syndrome, or small bowel resection)
• No seizure disorder
• No significant traumatic injury within 4 weeks prior to study entry
• No second primary malignancy except any of the following:
• Carcinoma in situ of the cervix
• Nonmelanoma skin cancer
• Prior malignancy diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
• History of low-grade (Gleason score ≤ 6) localized prostate cancer even if diagnosed 500 msec or other significant ECG abnormality within the past 14 days
• No New York Heart Association class III or IV disease

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chemotherapy for advanced lung cancer
• Neoadjuvant or adjuvant therapy for lung cancer within the past 12 months allowed
• More than 12 months since prior immunotherapy and biologic therapy
• More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to skeletal metastases)
• At least 2 weeks since prior WBRT
• No radiotherapy to ≥ 25% of bone marrow
• No major surgery (i.e., laparotomy) or open biopsy within 4 weeks prior to study entry (2 weeks for minor surgery)
• Insertion of a vascular access device not considered major or minor surgery
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent grapefruit or grapefruit juice during AZD2171 treatment
• No concurrent drugs or biologics with proarrhythmic potential
• Concurrent palliative radiotherapy to nontarget sites (i.e., painful pre-existing bony metastasis) allowed with AZD2171 (chemotherapy is held until completion of radiotherapy)