Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine Hydrochloride in Treating Patients with Stage IV or Recurrent Non-small Cell Lung Cancer

Inclusion Criteria

• Histologic or cytologic diagnosis of adenocarcinoma non-small cell lung cancer
• Stage IV non-small cell lung cancer or recurrent disease which cannot be approached with curative intent
• First-line treatment with a standard platinum doublet chemotherapy regimen (carboplatin or cisplatin at standard dosing plus one of the following drugs at standard dosing: paclitaxel, docetaxel, vinblastine, vinorelbine, pemetrexed, or etoposide); patients who received platinum-based chemotherapy for localized lung cancer (either adjuvant chemotherapy following surgery or chemotherapy given in conjunction with definitive radiation) are eligible if their cancer has recurred within 6 months of platinum-based chemotherapy
• Must have recovered from toxic effects of prior chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Life expectancy of at least 12 weeks
• Must have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded as > 20 mm with conventional techniques or > 10 mm with spiral computed tomography [CT] scanning)
• Patients with prior malignancies are allowed, provided they have been treated with curative intent and have no evidence of active disease
• Patients must be capable of giving informed consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing
• Bilirubin =< 1.5 mg/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 X upper limit of normal
• Alkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
• Platelets > 100,000 cells/mm^3
• Hemoglobin > 9.0 g/dL
• Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
• Creatinine =< 1.5 mg/dL
• Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
• Negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening for patients of childbearing potential
• Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])

Exclusion Criteria

• Patients with epidermal growth factor receptor (EGFR) or transforming fusion gene EML4-ALK variant 4 (EML4-ALK) mutations
• ECOG performance status > 1
• Patients previously treated with gemcitabine or Abraxane
• Uncontrolled intercurrent illness including, but not limited to: uncontrolled ongoing infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Known human immunodeficiency virus (HIV) or hepatitis C
• Untreated central nervous system metastases; patients are eligible if they are clinically stable, off all steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, stereotactic radio surgery) ending at least 2 weeks prior to enrollment, or after surgical resection performed at least 2 weeks prior to enrollment
• Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent
• Pregnant or breast-feeding patients; men and women of reproductive potential may not participate in this study unless they have agreed to use an effective contraceptive method while in this study; (postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential); patients must agree to continue contraception for 3 months from the date of the last study drug administration