Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

• Time to progression [ Time Frame: From the date of informed consent until the first documentation of progressive disease, assessed up to 2 years ] [ Designated as safety issue: No ]
  Will report as median values with their respective 95% confidence intervals will be reported. Time to event distribution will be estimated using the Kaplan-Meier method.
• Overall survival [ Time Frame: Time elapsed from date of informed consent, until death, assessed up to 2 years ] [ Designated as safety issue: No ]
  Will report as median values with their respective 95% confidence intervals will be reported. Time to event distribution will be estimated using Kaplan-Meier method.
• Percentage of patients experiencing grade 3 or higher toxicity graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Assessed up to 2 years ] [ Designated as safety issue: Yes ]
• Overall percentage of patients experiencing toxicity within a clinically significant category (neutropenia, neutropenic fever, or neuropathy) [ Time Frame: Assessed up to 2 years ] [ Designated as safety issue: Yes ]

This research study examines the use of Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) in patients with lung cancer. Abraxane is a chemotherapy approved to treat patients with breast cancer. Doctors want to know if Abraxane is safe and effective in treating patients with advanced lung cancer and epidermal growth factor receptor (EGFR) mutations

PRIMARY OBJECTIVES:

I. To evaluate the overall response rate of weekly nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations following front-line therapy with EGFR tyrosine kinase inhibitors (TKI).

SECONDARY OBJECTIVES:

I. To evaluate the safety profile of weekly nab-paclitaxel in patients with advanced NSCLC with EGFR mutations following front-line therapy with an EGFR TKI.

II. To evaluate the time-to-progression and overall survival.

OUTLINE:

Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks and then every 3 months thereafter.

• Recurrent Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

• Drug: paclitaxel albumin-stabilized nanoparticle formulation
  Given IV
  Other Names:

  • ABI-007
  • nab paclitaxel
  • nab-paclitaxel
  • nanoparticle albumin-bound paclitaxel
• Other: laboratory biomarker analysis
  Correlative studies

Inclusion Criteria:

• Pathologically confirmed non-small cell lung cancer with documented EGFR mutation in tumor deoxyribonucleic acid (DNA)
• At least one site of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
• Progressive disease with radiographic evidence of disease progression per investigator assessment during therapy with an EGFR tyrosine kinase inhibitor in the metastatic setting; patients may continue EGFR inhibitor therapy throughout the screening period until the day prior to nab-paclitaxel treatment initiation
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at the time of informed consent
• Platelet count >= 100,000/UL
• Absolute neutrophil count >= 1,500/UL
• Hemoglobin >= 9 g/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = < 2.5 times upper limit of normal
• Alkaline phosphatase =< 2.5 times upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
• Bilirubin =< 1.5mg/dL
• Creatinine =< 1.5mg/dL
• Women of child-bearing potential (WOCP) and sexually active men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, during treatment and for three months after completing treatment
• Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
• Life expectancy of >= 12 weeks
• Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

• Prior conventional cytotoxic chemotherapy for metastatic or recurrent disease; prior adjuvant, neoadjuvant or chemoradiotherapy for NSCLC is permitted, provided at least 6 months elapsed prior to documented metastatic recurrence
• Patient is < 5 years free of another primary malignancy, except: a) if the other malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other primary malignancy is not considered clinically significant and is requiring no active intervention
• Progressive or symptomatic central nervous system (CNS) metastases; patients with known brain metastasis must have stable disease following treatment with surgery, radiation or both; in addition, they must be off corticosteroids
• Radiotherapy within 7 days of study treatment
• Peripheral neuropathy grade 2 or greater
• Grade III/IV congestive heart failure, as defined by New York Heart Association (NYHA) criteria, or myocardial infarction within 6 months
• Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
• Patient has known chronic liver disease, e.g. diagnosis of chronic active hepatitis or cirrhosis
• Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery
• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
• Pregnant or breast feeding females