Nab-Paclitaxel with or without Carboplatin in Treating Elderly Patients with Stage IV Non-small Cell Lung Cancer
Basic Trial Information
70 and over
1403013529 NCI-2016-00947, NCT02590003
This randomized phase II trial studies how well nab-paclitaxel with or without carboplatin works in treating elderly patients with stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as nab-paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Further Study Information
I. To compare the treatment failure-free survival rate in high-risk elderly patients, identified by geriatric assessment, treated with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) or single agent nab-paclitaxel in advanced non-small cell lung cancer.
I. To evaluate grade 3-5 toxicities between the two randomization arms.
II. To evaluate overall response rate between the two randomization arms.
III. To evaluate progression free survival between the two randomization arms.
IV. To evaluate symptom assessment between the two randomization arms.
V. To evaluate overall survival between the two randomization arms.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM A: Patients receive carboplatin intravenously (IV) over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for up to 9 months.
Patient able and willing to comply with study procedures as per protocol, including the geriatric assessment at the time of study enrollment
Patient able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures
Patients must have histological or cytological confirmed primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous, or unspecified); disease must be stage IV non-small cell lung cancer (NSCLC); disease may be either newly diagnosed or recurrent after previous surgery and/or irradiation; primary or metastatic site for biopsy is allowed
Patients may have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease; measurable disease must be assessed within 30 days prior to registration per response evaluation criteria in solid tumors (RECIST) version (v)1.1; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non- measurable disease must be assessed within 30 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
Prior chemotherapy for curative intent is permitted providing the cytotoxic chemotherapy was completed >= 12 months prior to enrollment; patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 30 days prior to registration; patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day; any radiation therapy completed prior to chemotherapy, except gamma-knife radiosurgery, 1 week prior to chemotherapy
Life expectancy of greater than 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Patients must have a comprehensive geriatric assessment and chemotherapy toxicity assessment score between 7-17
Total bilirubin =< 1.5 mg/dL (unless there is a known history of Gilbert's syndrome)
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
Alkaline phosphatase =< 2.5 X upper limit of normal in the absence of liver or bone metastasis, or =< 5.0 x upper limit of normal range if bone or liver metastases
Creatinine clearance > 25 mL/min or creatinine =< 1.5 mg/dL
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are eligible if they have been on antiretrovirals (ARVs) for >= 6 months and undetectable viral loads
Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
Ability to understand and the willingness to sign a written informed consent document in English or a Spanish consent “short form”; if language other than English or Spanish, then interpreter will be used to sign English consent form
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Patients who have had palliative chemotherapy prior to entering the study < 12 months from enrollment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Patients may not be receiving any other investigational agents or have received immunotherapy
Known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutated disease (molecular testing not required prior to study entry)
History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, or nab-paclitaxel
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Preexisting peripheral neuropathy of grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v 4.0)
Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for >= 2 weeks prior to signing informed consent form; magnetic resonance imaging of the brain (or computed tomography scan w/contrast) is preferred for diagnosis
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.
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