Single Arm on the Tolerability of Weekly Nab-paclitaxel

Completed · Phase 2

Conditions studied: Non Small Cell Lung Cancer (NSCLC)

In brief

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)

Key facts

Study ID

NCT01702844

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

42

Starts

2013-06-25

Expected to finish

2019-07-12

Last updated by the study team

2020-10-08

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Rex Healthcare — Raleigh, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Bon Secours Virginia Health System — Midlothian, Virginia, United States
• Swedish Cancer Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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