Single Arm on the Tolerability of Weekly Nab-paclitaxel

NCT01702844 | Completed Phase 2 Results DMC

• 1 other identifier: LCCC 1210
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 8

Brief 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)

Conditions

Non Small Cell Lung Cancer (NSCLC)

Keywords

Nab paclitaxel; Abraxane; First Line; Non small cell lung cancer; NSCLC; Phase II; Non-Randomized; Elderly; Lineberger; UNC; LCCC 1210

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Without Any Adverse Events Grade 3 or Higher

  Tolerability of weekly nab-paclitaxel, as measured by occurrence of Grade 3 or worse toxicity after 6 cycles or 3 weeks after discontinuation of treatment, for those who came off treatment earlier as measured by the NCI Common Terminology Criteria for Adverse Events CTCAE, version 4. The CTCAE is a descriptive terminology utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

  168 days after start of treatment (6 cycles) (or 3 weeks after discontinuation of treatment, for those who come off treatment earlier)

Secondary Outcomes (3)

• Median Overall Survival

  up to 2 years after end of treatment (treatment lasts up to 168 days (up to 6 cycles of 28 days each))

• Median Progression Free Survival

  up to 2 years after end of treatment (treatment lasts up to 168 days (up to 6 cycles of 28 days each))

• Overall Response Rate

  168 days after start of treatment (6 cycles) (or 3 weeks after discontinuation of treatment, for those who come off treatment earlier)

Study Arms (1)

nab paclitaxel

EXPERIMENTAL

Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle

Drug: Nab-Paclitaxel

Interventions

Nab-Paclitaxel DRUG

Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15

Also known as: Abraxane

nab paclitaxel

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

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
• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Celgene: collaborator

Study Sites (8)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Rex Healthcare

Raleigh, North Carolina, 27607, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Bon Secours Virginia Health System

Midlothian, Virginia, 23114, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Related Links

• Lineberger Comprehensive Cancer Center homepage
• National Cancer Institute (NCI) homepage

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Robin V. Johnson
• Organization: University of North Carolina Lineberger Comprehensive Cancer Center

Robin_V_Johnson@med.unc.edu

919-966-1125

Study Officials

• Jared Weiss, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: October 8, 2012
• Study Start: June 25, 2013
• Primary Completion: June 23, 2017
• Study Completion: July 12, 2019
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Locations

US (8)