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



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/11/2018
Start Date:November 6, 2012
End Date:May 23, 2027

Use our guide to learn which trials are right for you!

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

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.

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.

Inclusion Criteria:

- 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

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

- 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
We found this trial at
12
sites
Anchorage, Alaska 99508
Principal Investigator: Jeanne E. Anderson
Phone: 907-212-3629
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Anchorage, Alaska 99508
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Anchorage, Alaska 99508
Principal Investigator: Jeanne E. Anderson
Phone: 907-562-0321
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Jack O. Hensold
Phone: 406-585-5070
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
?
mi
from
Bozeman, MT
Click here to add this to my saved trials
Kennewick, Washington 99336
Principal Investigator: Thomas A. Rado
Phone: 509-783-4637
?
mi
from
Kennewick, WA
Click here to add this to my saved trials
Mount Vernon, Washington 98274
Principal Investigator: Kiarash Kojouri
Phone: 360-428-8450
?
mi
from
Mount Vernon, WA
Click here to add this to my saved trials
Port Angeles, Washington 98362
?
mi
from
Port Angeles, WA
Click here to add this to my saved trials
Redmond, Washington 98052
Principal Investigator: Eric Y. Chen
Phone: 206-225-7893
?
mi
from
Redmond, WA
Click here to add this to my saved trials
Seattle, Washington 98109
Principal Investigator: Christina S. Baik
Phone: 206-288-7557
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Spokane, Washington 99216
Principal Investigator: Arvind Chaudhry
Phone: 509-462-2273
?
mi
from
Spokane, WA
Click here to add this to my saved trials
314 Martin Luther King Junior Way
Tacoma, Washington 98405
(253) 403-5200
Principal Investigator: John W. Rieke
Phone: 253-403-1030
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Wenatchee, Washington 98801
Principal Investigator: Lindsay C. Overton
Phone: 509-663-8711
?
mi
from
Wenatchee, WA
Click here to add this to my saved trials