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SCCA at EvergreenHealth

ABRAXANE® (Nab-Paclitaxel) for Advanced NSCLC (7755)
A Phase II Study of Weekly ABRAXANE® (Nab-Paclitaxel) for Patients with Advanced NSCLC with EGFR Mutations Following Front-Line Therapy with EGFR Tyrosine Kinase Inhibitors
Status Conditions Phase Study ID
Recruiting Lung Cancer Phase II 7755
NCT01620190
Summary

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.


Investigator
Christina Baik
Location    
Seattle Cancer Care Alliance 800-804-8824  
Bozeman Deaconess Cancer Center, Bozeman, MT 406-585-5070  
Olympic Medical Center, Sequim WA 360-683-9895  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Columbia Basin Hematology & Oncology, Kennewick, WA 509-783-4637  
SCCA at EvergreenHealth 425-899-3337  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
  • 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 >= 9g/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
Exclusions (conditions that would prevent participation in this study)
  • Prior 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
Last Updated
September 24, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.