Lung Cancer Clinical Trial
Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly
Summary
Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly subjects (≥ 70 years old) with advanced NSCLC
Full Description
This is a Phase IV, randomized, open-label, multicenter study of continuous weekly versus weekly times three with one-week break nab-paclitaxel in combination with carboplatin as first-line treatment in elderly subjects (≥ 70 years old) with advanced non small cell lung cancer who have not received prior chemotherapy for their advanced disease and are not candidates for curative surgery or radiation therapy. The primary study endpoint is the percentage of subjects with either peripheral neuropathy or myelosuppression adverse events. Patients will continue treatment until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study, according to local standard of care. Patients will have radiographic evaluations every 6 weeks while on treatment.
Eligibility Criteria
Inclusion Criteria: -
Inclusion Criteria: -
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).
Male subjects must: Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following study drug discontinuation, even if he has undergone a successful vasectomy.
Exclusion Criteria:
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.
2. 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).
5. 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.
6. Venous thromboembolism within 1 month prior to signing informed consent form.
7. 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.
9. 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.
10. 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.
11.History of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.
12. Treatment with any investigational product within 28 days prior to signing the informed consent form.
13. 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.
16. 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.
17. Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
18. Any medical condition that confounds the ability to interpret data from the study.
19. 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).
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 55 Locations for this study
Tucson Arizona, 85715, United States
Hot Springs Arkansas, 71913, United States
Bakersfield California, 93309, United States
Fullerton California, 92835, United States
Gilroy California, 95020, United States
Oxnard California, 93030, United States
Santa Maria California, 93454, United States
Santa Monica California, 90404, United States
Denver Colorado, 80218, United States
Grand Junction Colorado, 81501, United States
Boca Raton Florida, 33486, United States
Jacksonville Florida, 32207, United States
Ocala Florida, 34471, United States
Orlando Florida, 32804, United States
Evanston Illinois, 60201, United States
Niles Illinois, 60714, United States
Indianapolis Indiana, 46237, United States
Wichita Kansas, 67214, United States
Paducah Kentucky, 42003, United States
Marrero Louisiana, 70072, United States
New Orleans Louisiana, 70123, United States
Baltimore Maryland, 21237, United States
Worcester Massachusetts, 01608, United States
Detroit Michigan, 48202, United States
Omaha Nebraska, 68114, United States
Lebanon New Hampshire, 03756, United States
Cherry Hill New Jersey, 08003, United States
East Brunswick New Jersey, 08816, United States
Livingston New Jersey, 07039, United States
Morristown New Jersey, 07962, United States
Somerville New Jersey, 08876, United States
Sparta New Jersey, 07871, United States
Bronx New York, 10461, United States
Brooklyn New York, 11212, United States
Johnson City New York, 13790, United States
Lake Success New York, 11042, United States
Syracuse New York, 13215, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28204, United States
Winston-Salem North Carolina, 27103, United States
Youngstown Ohio, 44501, United States
Lawton Oklahoma, 73505, United States
Corvallis Oregon, 97330, United States
Portland Oregon, 97210, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15212, United States
Amarillo Texas, 79106, United States
Dallas Texas, 75246, United States
Galveston Texas, 77555, United States
Longview Texas, 75601, United States
Seattle Washington, 98101, United States
Vancouver Washington, 98684, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.