Bronchial Artery Infusion of Gemcitabine in Treating Patients With Recurrent or Progressive Non-Small Cell Lung Cancer

Inclusion Criteria:

Cytologically or histologically confirmed non-small cell lung cancer meeting the following criteria:

No T2 lesions invading the visceral pleura, causing atelectasis, or proximal to an obstructing pneumonia
No T3 lesions invading the chest wall (including the parietal pleura, musculature, and/or rib), mediastinal pleura, diaphragm, or pericardium
No T4 lesions invading the heart, great vessels, carina, or esophagus
Must have disease that is incurable by standard treatment, defined as a minimum of first-line therapy with a platinum-containing regimen and second-line therapy with docetaxel, pemetrexed disodium, or erlotinib hydrochloride
Measurable or nonmeasurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Life expectancy ≥ 12 weeks
Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count (ANC) ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Serum creatinine ≤ 3.0 mg/dL
Total bilirubin < 1.5 times upper limit of normal
International normalized ratio (INR) ≤ 1.3
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective non-hormonal contraception

Exclusion Criteria:

Superior vena cava syndrome or superior sulcus tumors
Patients with airway obstructing lesions, or patients experiencing hemoptysis, dyspnea, chest pain, and/or copious sputum production may be eligible after careful consideration by the study physicians
Prior or concurrent malignancy except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, stage I carcinoma of the prostate with normal PSA, or other cancer from which the patient has been disease free for 3 years

Medical conditions that would make this protocol unreasonably hazardous, in the opinion of the treating physician, including any of the following:

Uncontrolled infection (including HIV)
Poorly controlled diabetes mellitus
Active cardiac disease (i.e., unstable angina, myocardial infarction within the past 6 months, or congestive heart failure)
Other serious medical illness that would limit survival to < 3 months, or psychiatric condition that would prevent informed consent, unless a legal guardian is available
Must consent to participate in the laboratory study, "Population Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with Solid Tumors" during course 1

More than 6 months since prior gemcitabine hydrochloride

More than 2 weeks since other prior chemotherapy
More than 4 weeks since prior radiotherapy