Single Arm on the Tolerability of Weekly Nab-paclitaxel

Study summary

The purpose of this study is to evaluate the safety and efficacy of weekly nab-paclitaxel for a second-line treatment in elderly subjects, 70 years of age or greater, with non-small cell lung cancer (NSCLC)

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNab-Paclitaxel

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 8, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?UNC Lineberger Comprehensive Cancer Center

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: UNC Lineberger Comprehensive Cancer Center
Interventions being studied: Drug: Nab-Paclitaxel

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Chemotherapy→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Signed written informed consent
Male or female patient
Greater than or equal to 70 years of age
Diagnosis of NSCLC histologically or cytologically confirmed
Internal Association for the Study of Lung Cancer Version 7 Stage IV disease or recurrence after prior surgery or radiotherapy
Progression following one line of prior chemotherapy consisting of a platinum agent plus a standard cytotoxic partner agent other than a taxane, typically pemetrexed gemcitabine or vinorelbine
A single agent non cytoxic regimen if the patient has a molecular change that the non cytotoxic regimen would be expected to be efficacious for epidermal growth factor receptor (EGFR) mutation for erlotinib and (EML4) anaplastic lymphoma kinase (ALk) or ROS1 for crizotinib
Eastern Cooperative Oncology Group performance status 0 to 2
Adequate organ and bone marrow function as defined by
Absolute neutrophil count greater than or equal to 1500 cells/mm3
Creatinine less than or equal to 1.5 mg dL
Total bilirubin less than or equal to 1.5 mg dL
Alkaline phosphatase less than or equal to 2.5 x upper limit of normal
Alanine aminotransferase less than or equal to 2.5 x upper limit of normal
Aspartate aminotransferase less than or equal to 2.5 upper limit of normal
Recovered from all reversible toxicities related to their previous treatment to less than or equal to grade 1 or baseline
Patients must have equal to grade 2 pre existing peripheral neuropathy
Women of childbearing potential and sexually active men must agree to use effective contraception prior to study entry for the duration of study participation and for three months after completing treatment. Adequate contraception is defined as any medically recommended method as per standard of care
Negative serum or urine bhCG pregnancy test at screening for patients of childbearing potential
Patients with brain metastases may participate if they have undergone appropriate treatment for the lesions are at least two weeks post treatment without evidence for post treatment progression have no significant neurologic symptoms and no longer require steroids for the reason of brain metastases. Patients with symptoms suggestive of central nervous system (CNS) metastases should be evaluated with imaging prior to study participation

Reasons someone may not be able to joinExclusion criteria

Prior taxane therapy for any indication
Less than 3 weeks elapsed since prior exposure to chemotherapy
Pre existing neuropathy greater than grade 1
Other active invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years localized squamous cell carcinoma of the skin basal cell carcinoma of the skin, carcinoma in situ of teh cervix or other malignancies requiring locally ablative therapy only will not result in exclusion
Concomitant anticancer therapy immunotherapy or radiation therapy within prior 4 weeks
Have received treatment within the last 30 days prior to study entry with any drug that has not receive regulatory approval for an indication at the time of study entry
Uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring IV antibiotics symptomatic congestive heart failure unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements
Pregnant women are excluded due to the potential for teratogenic or abortifacient effects of nab paclitaxel because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued prior to participation of the mother on study
Known hypersensitivity to protein bound paclitaxel
Any other concurrent condition that in the investigators opinion would jeopardize compliance with the protocol

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Highlands Oncology GroupFayetteville, Arkansas
UNC Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina
Rex HealthcareRaleigh, North Carolina
Cleveland ClinicCleveland, Ohio
Fox Chase Cancer CenterPhiladelphia, Pennsylvania
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
Bon Secours Virginia Health SystemMidlothian, Virginia
Swedish Cancer InstituteSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 8, 2020. Always confirm current availability with the study team.

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