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

NCT01620190 | Completed Phase 2 Results

• 4 other identifiers: 7755NCI-2012-00865P30CA015704RG1712044
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 12

Brief 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 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.

Conditions

Recurrent Non-Small Cell Lung Carcinoma; Stage IV Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria

  The response rate as the proportion and 95% confidence interval of patients who achieved a complete response or partial response will be calculated.

  Assessed every two cycles from date of first study therapy until documented disease progression, date of death, unacceptable toxicity, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.

Secondary Outcomes (4)

• Overall Percentage of Patients Experiencing Toxicity Within a Clinically Significant Category Defined as Neutropenia, Neutropenic Fever, or Neuropathy.

  Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.

• Overall Survival

  Assessed from date of patient consent until date of death from any cause or withdrawal of patient consent, whichever occurs first, assessed up to 305 weeks.

• Overall Percentage of Patients Experiencing Grade 3 or Higher Toxicity.

  Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.

• Time to Progression.

  Assessed from date of patient consent until documented disease progression, date of death from any cause, start of new anti-cancer therapy, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.

Study Arms (1)

Treatment (paclitaxel albumin-stabilized nanoparticle formula)

EXPERIMENTAL

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

Other: Laboratory Biomarker Analysis; Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (paclitaxel albumin-stabilized nanoparticle formula)

Paclitaxel Albumin-Stabilized Nanoparticle Formulation DRUG

Given IV

Also known as: ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, nab-paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, protein-bound paclitaxel

Treatment (paclitaxel albumin-stabilized nanoparticle formula)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator
• Celgene Corporation: collaborator

Study Sites (12)

Anchorage Oncology Centre

Anchorage, Alaska, 99508, United States

Location

Katmai Oncology Group

Anchorage, Alaska, 99508, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

Skagit Valley Hospital

Mount Vernon, Washington, 98274, United States

Location

Olympic Medical Center

Port Angeles, Washington, 98362, United States

Location

Group Health Cooperative

Redmond, Washington, 98052, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Spokane Valley Cancer Center-Mission

Spokane, Washington, 99216, United States

Location

Multicare Health System

Tacoma, Washington, 98415, United States

Location

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, 98801, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Taxes; Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Research Manager
• Organization: University of Washington

smasters@seattlecca.org

206-606-7445

Study Officials

• Christina Baik

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: December 2, 2012
• Primary Completion: October 24, 2017
• Study Completion: April 29, 2019
• Last Updated: July 16, 2021
• Results First Posted: July 16, 2021

Record last verified: 2021-06

Locations

US (12)