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Clinical Trial Detail

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

Complete title: A Phase II Study of Weekly ABRAXANE® for Patients with Advanced NSCLC with EGFR Mutations or with Durable Response to an EGFR Tyrosine Kinase Inhibitor following Front-Line Therapy with EGFR Tyrosine Kinase Inhibitors

Research Study Number       7755
Principal Investigator       Christina Baik
Phase       II

Look up trial at NIH

Research Study Description

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 lung cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) and epidermal growth factor receptor (EGFR) mutations.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- Pathologically confirmed non-small cell lung cancer with documented EGFR mutation in tumor deoxyribonucleic acid (DNA) or complete/partial response to first line EGFR tyrosine kinase inhibitors with > or = to 6 months duration of response in patients who do not have a confirmed EGFR mutation

- At least one site of measurable disease as determined by the Investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

- 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 =< 1.5 mg/dL

- Creatinine =< 1.5 mg/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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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

- A single dose of a platinum doublet discontinued due to intolerability without evidence of disease progression is permitted

- 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

Other exclusion criteria may apply.

Research Study Number       7755
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-606-1024

Lung Cancer; Solid Tumors; Lung Carcinoma, Non-Small-Cell (NSCLC); Carcinoma, Bronchogenic

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.

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