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

Completed · Phase 4

Conditions studied: Non-Small Cell Lung Cancer, Carcinoma, Squamous Cell Carcinoma, Adenocarcinoma, Carcinoma, Large Cell, Lung Neoplasm

In brief

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

Key facts

Study ID

NCT02151149

Run by

Celgene

People needed

143

Starts

2014-06-09

Expected to finish

2017-07-14

Last updated by the study team

2018-09-24

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 1. 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).

Where it is running

• Genesis Cancer Center — Hot Springs, Arkansas, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• Saint Jude Heritage Medical Center — Fullerton, California, United States
• Global Cancer Research Institute (GCRI), Inc. — Gilroy, California, United States
• Ventura County Hematology-Oncology Specialists — Oxnard, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• University of California Los Angeles — Santa Monica, California, United States
• Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States
• St Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
• Lynn Cancer Institute — Boca Raton, Florida, United States
• Baptist Cancer Inst — Jacksonville, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Northshore University Healthsystem Research Institute — Evanston, Illinois, United States
• Oncology Specialists, S.C. — Niles, Illinois, United States
• Franciscan St. Francis Health — Indianapolis, Indiana, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Western Kentucky Hematology and Oncology Group — Paducah, Kentucky, United States
• West Jeffersion Medical Center — Marrero, Louisiana, United States
• Ochsner Medical Institutions — New Orleans, Louisiana, United States
• Medstar Health Research Institute — Baltimore, Maryland, United States
• Reliant Medical Group — Worcester, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Arizona Clinical Research Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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