Single Arm on the Tolerability of Weekly Nab-paclitaxel

UNC Lineberger Comprehensive Cancer Center

Status and phase

Completed

Phase 2

Conditions

Non Small Cell Lung Cancer (NSCLC)

Treatments

Drug: Nab-Paclitaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01702844

LCCC 1210

Details and patient eligibility

About

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)

Full description

This will be a non-randomized phase II study evaluating the safety and efficacy of weekly nab-paclitaxel for second-line treatment in 42 elderly patients, who are 70 years of age or greater with non-small cell lung cancer (NSLC). Patients will be required to have progressed on a single prior regimen. Nab-paclitaxel 100mg/m2 will be administered intravenously, weekly for 3 weeks of every 4-week cycle. After every two cycles of therapy, imaging will be performed to assess for response. Patients will be eligible to continue receiving therapy until the time of disease progression.

Primary Objectives To evaluate the tolerability of weekly nab-paclitaxel in older adults with advanced lung cancer who have progressed on at least 1 prior regimen after 6 cycles or 3 weeks after discontinuation of treatment, for those who come off treatment earlier.

Secondary Objectives To estimate overall survival To estimate progression-free survival To estimate the response rate

Correlative Objectives To explore baseline components of the Geriatric Assessment (GA) as predictors of chemotherapy tolerance and overall survival To explore the use of p16 measurements in the elderly as predictors of chemotherapy tolerance and overall survival To explore the impact of weekly nab-paclitaxel treatment on quality of life, as measured by Lung Cancer Symptom Scale (LCSS) and Functional Assessment of Cancer Therapy-Lung (FACT-L).

Enrollment

42 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion 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

Exclusion 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