Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly

NCT02151149 | Completed Phase 4 Results

• 1 other identifier: ABI-007-NSCL-005
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 55

Brief Summary

Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly subjects (≥ 70 years old) with advanced NSCLC

Conditions

Non-Small Cell Lung Cancer; Carcinoma; Squamous Cell Carcinoma; Adenocarcinoma; Carcinoma, Large Cell; Lung Neoplasm

Keywords

NSCLC advanced non-small cell lung cancer squamous adenocarcinoma large cell carcinoma lung cancer elderly first line treatment abraxane carbo nab-paclitaxel

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Either Peripheral Neuropathy ≥ Grade 2 or Myelosuppression Adverse Events (AEs) ≥ Grade 3 Based on Local Laboratory Values

  Peripheral neuropathy (sensory or motor) assessment was done at screening, on Days 1, 8, 15 of every treatment cycle, at the End-of-Treatment visit and at the 28-day Follow-up Visit. Changes in neuropathy grade from baseline was reported as an AE as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Myelosuppression in participants receiving chemotherapy may have manifested as neutropenia, thrombocytopenia, or anemia. Grade 3 neutropenia including an absolute neutropenia count (ANC) of 500 to 1,000 cells/mm\^3; anemia hemoglobain levels (Hgb) \<8.0 - 6.5 g/dL; \<4.9 - 4.0 mmol/L; \<80 - 65 g/L; transfusion indicated; and thrombocytopenia with platelet levels \<100,000 cells/mm\^3.

  From the date of the first dose of investigational product (IP) until 28 days after the last dose of IP; up to data cut-off date of 20 November 2016; The median treatment duration for Arms A and B were 3.04 months and 5.17 months respectively.

Secondary Outcomes (9)

• Number of Participants With Treatment Emergent Adverse Events During the Treatment Period

  From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017; maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively.

• Percentage of Participants With at Least 1 Treatment Emergent Adverse Event With Action Taken as Study Drug Withdrawn

  From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017 the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively

• Dose Intensity Per Week of Nab-Paclitaxel During the Entire Study

  From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively

• Dose Intensity Per Week of Carboplatin During the Entire Study

  From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively

• Percentage of Participants With Dose Reductions During the Entire Study

  From the first dose of study treatment to discontinuation date of study treatment; up to date cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively

Study Arms (2)

Arm A: nab-Paclitaxel and Carboplatin (Every 21 days)

OTHER

nab-Paclitaxel 100 mg/m2 intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 and Carboplatin AUC = 6 mg\*min/mL IV following nab-paclitaxel infusion on Day 1 of every 21-day treatment cycle

Drug: nab-paclitaxel; Drug: Carboplatin

Arm B: nab-Paclitaxel and Carboplatin (Every 28 days)

OTHER

nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment followed by one-week break and Carboplatin AUC = 6 mg\*min/mL IV following nab-paclitaxel infusion on Day 1 of each 21-day treatment followed by one-week break

Drug: nab-paclitaxel; Drug: Carboplatin

Interventions

nab-paclitaxel DRUG

Also known as: Abraxane

Arm A: nab-Paclitaxel and Carboplatin (Every 21 days); Arm B: nab-Paclitaxel and Carboplatin (Every 28 days)

Carboplatin DRUG

Arm A: nab-Paclitaxel and Carboplatin (Every 21 days); Arm B: nab-Paclitaxel and Carboplatin (Every 28 days)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70 years at the time of signing the Informed Consent Form.
• Understand and voluntarily provide written informed consent prior to the conduct of any study related assessments/procedures.
• Able to adhere to the study visit schedule and other protocol requirements.
• Histologically or cytologically confirmed locally advanced or metastatic non small cell lung cancer who are not candidates for curative surgery or radiation therapy.
• No other current active malignancy requiring anticancer therapy.
• Radiographically documented measurable disease per RECIST v 1.1
• No prior chemotherapy for the treatment of metastatic disease. Adjuvant chemotherapy is permitted providing that cytotoxic chemotherapy was completed 12 months prior to signing the informed consent form (ICF) and without disease recurrence. Participans with previously known epidermal growth factor receptor mutation or anaplastic lymphoma kinase gene translocation must have failed or had intolerance to one treatment with epidermal growth factor receptor tyrosine kinase inhibitor or anaplastic lymphoma kinase inhibitor therapy, respectively.
• Absolute neutrophil count ≥ 1500 cells/cubic millimetre.
• Platelets ≥ 100,000 cells/cubic millimetre.
• Hemoglobin ≥ 9 grams/decilitre.
• Aspartate transaminase/serum glutamic oxaloacetic transaminase/ alanine transaminase/serum glutamic pyruvic transaminase ≤ 2.5 × upper limit of normal range or ≤ 5.0 × upper limit of normal range if liver metastases.
• Total bilirubin ≤ 1.5 millilitre/decilitre (unless there is a known history of Gilberts Syndrome).
• Creatinine clearance \> 40 millilitre/minute calculated using Cockcroft-Gault equation (if renal impairment is suspected 24 hour urine collection for measurement is required).
• Eastern Cooperative Oncology Group performance status 0 or 1.
• Females who (1) have undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have been naturally postmenopausal for at least 24 consecutive months (ie, has not had menses at any time during the preceding 24 consecutive months).

You may not qualify if:

• \. Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for ≥ 4 weeks prior to signing Informed consent form. Magnetic Resonance Imaging of the brain (or Computed Tomography scan w/contrast) is preferred for diagnosis.
• \. History of leptomeningeal disease. 3. Only evidence of disease is non measurable. 4. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).
• \. Participant has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting investigational product, and/or from whom ≥ 30% of the bone marrow was irradiated. Prior radiation therapy to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
• \. Venous thromboembolism within 1 month prior to signing informed consent form.
• \. Current congestive heart failure (New York Heart Association Class II-IV). 8. History of the following within 6 months prior to first administration of a study drug: a myocardial infarction, severe/unstable angina pectoris,coronary/peripheral artery bypass graft, New York Heart Association Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant Electrocardiogram abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
• \. Participant has a known infection with hepatitis B or C, or history of human immunodeficiency virus infection, or participant is receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications.
• \. Participant has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
• History of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.
• \. Treatment with any investigational product within 28 days prior to signing the informed consent form.
• \. History of allergy or hypersensitivity to nab-paclitaxel or carboplatin. 14. Currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices. 15. Any other clinically significant medical condition, psychiatric illness, and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol or which, in the views of investigator, preclude combination chemotherapy.
• \. Participant has any other malignancy within 5 years prior to randomization. Exceptions include the following: squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer Tumor, Lymph Node, Metastatic (TNM stage of T1a or T1b). All treatment of which should have been completed 6 months prior to signing Informed consent form.
• \. Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
• \. Any medical condition that confounds the ability to interpret data from the study.
• \. Females who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time during the preceding 24 consecutive months).

Sponsors & Collaborators

• Celgene: lead

Study Sites (55)

Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

Location

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Saint Jude Heritage Medical Center

Fullerton, California, 92835, United States

Location

Global Cancer Research Institute (GCRI), Inc.

Gilroy, California, 95020, United States

Location

Ventura County Hematology-Oncology Specialists

Oxnard, California, 93030, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, 93454, United States

Location

University of California Los Angeles

Santa Monica, California, 90404, United States

Location

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, 80218, United States

Location

St Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, 81501, United States

Location

Lynn Cancer Institute

Boca Raton, Florida, 33486, United States

Location

Baptist Cancer Inst

Jacksonville, Florida, 32207, United States

Location

Ocala Oncology Center

Ocala, Florida, 34471, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Northshore University Healthsystem Research Institute

Evanston, Illinois, 60201, United States

Location

Oncology Specialists, S.C.

Niles, Illinois, 60714, United States

Location

Franciscan St. Francis Health

Indianapolis, Indiana, 46237, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Location

Western Kentucky Hematology and Oncology Group

Paducah, Kentucky, 42003, United States

Location

West Jeffersion Medical Center

Marrero, Louisiana, 70072, United States

Location

Ochsner Medical Institutions

New Orleans, Louisiana, 70123, United States

Location

Medstar Health Research Institute

Baltimore, Maryland, 21237, United States

Location

Reliant Medical Group

Worcester, Massachusetts, 01608, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202-268, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Center for Cancer and Hematologic Disease

Cherry Hill, New Jersey, 08003, United States

Location

Regional Cancer Care Associates LLC

East Brunswick, New Jersey, 08816, United States

Location

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Carol G Simon Cancer Center

Morristown, New Jersey, 07962, United States

Location

Somerset Hematology-Oncology Associates

Somerville, New Jersey, 08876, United States

Location

Regional Cancer Care Associates LLC- Sparta division

Sparta, New Jersey, 07871, United States

Location

Brookdale University Hospital and Medical Center

Brooklyn, New York, 11212, United States

Location

Broome Oncology, LLC

Johnson City, New York, 13790, United States

Location

Clinical Research Alliance

Lake Success, New York, 11042, United States

Location

SUNY Upstate Medical University Medicine Oncology

Syracuse, New York, 13215, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Lineberger Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Forsyth Memorial Hospital, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

St Elizabeth Hospital

Youngstown, Ohio, 44501, United States

Location

Cancer Centres of Southwest Okahoma Research

Lawton, Oklahoma, 73505, United States

Location

Good Samaritan Hospital Corvalis

Corvallis, Oregon, 97330, United States

Location

Oregon Health and Science University

Portland, Oregon, 97210, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Medical College

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Texas Oncology, P.A.-Amarillo

Amarillo, Texas, 79106, United States

Location

Baylor University Medical Center at Dallas

Dallas, Texas, 75246, United States

Location

UTMB Galveston

Galveston, Texas, 77555-0565, United States

Location

Texas Oncology, PA - Longview

Longview, Texas, 75601, United States

Location

Virginia Mason Cancer Center

Seattle, Washington, 98101, United States

Location

Northwest Cancer Specialists, P.C.

Vancouver, Washington, 98684, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma; Carcinoma, Squamous Cell; Adenocarcinoma; Carcinoma, Large Cell; Lung Neoplasms

Interventions

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

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes

Results Point of Contact

• Title: Anne McClain, Senior Manager
• Organization: Celgene Corporation

ClinicalTrialDisclosure@Celgene.com

888-260-1599

Study Officials

• Teng Jin Ong

  Celgene

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: June 9, 2014
• Primary Completion: July 14, 2017
• Study Completion: July 14, 2017
• Last Updated: September 24, 2018
• Results First Posted: September 24, 2018

Record last verified: 2018-08

Locations

US (55)