Single Arm on the Tolerability of Weekly Nab-paclitaxel

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01702844
First received: September 25, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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)


Condition Intervention Phase
Non Small Cell Lung Cancer (NSCLC)
Drug: Nab-Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LCCC 1210 - Phase II, Multicenter, Single Arm Study of the Tolerability of Weekly Nab-paclitaxel as Second Line Treatment for Elderly Patients With Advanced Lung Cancer

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Number of subjects with adverse events [ Time Frame: 6 cycles or 6 months ] [ Designated as safety issue: Yes ]
    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 CTCAE, version 4


Secondary Outcome Measures:
  • Post-baseline efficacy assessment [ Time Frame: 14 months up to 2 years ] [ Designated as safety issue: Yes ]
    Efficacy outcomes include overall survival, overall response rate,and progression free survival. All subjects will be evaluable for overall survival after at least one dose of nab-paclitaxel. Overall response rate and progression free survival are assessed for subjects who have received at least 2 cycles of therapy and have at least one post-baseline efficacy assessment after Cycle 2.


Other Outcome Measures:
  • Measurable lesion [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Presence of at least one measurable lesion that can be accurately measured in at least one dimension with the longest diameter a minimum size of greater than or equal to 10 mm by CT scan


Estimated Enrollment: 42
Study Start Date: October 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nab paclitaxel
Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle
Drug: Nab-Paclitaxel
Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15
Other Name: Abraxane

Detailed 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 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 LCSS and FACT-L.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 EGFR mutation for erlotinib and EML4 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702844

Contacts
Contact: Jennifer Gournay, RN 919-843-5123 jennifer_gournay@med.unc.edu
Contact: Donna Rowe, RN 919-966-2152 donna_rowe@med.unc.edu

Locations
United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
Principal Investigator: Daniel Bradford, MD         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Rex Healthcare Recruiting
Raleigh, North Carolina, United States, 27607
Principal Investigator: Jeffrey Crane, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Nathan Pennell, MD         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Principal Investigator: Yanis Boumber, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: Liza Villaruz, MD         
United States, Washington
Swedish Cancer Institute Active, not recruiting
Seattle, Washington, United States, 98104
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Jared Weiss, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01702844     History of Changes
Other Study ID Numbers: LCCC 1210
Study First Received: September 25, 2012
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Nab paclitaxel
Abraxane
First Line
Non small cell lung cancer
NSCLC
Phase II
Non-Randomized
Elderly
Lineberger
UNC
LCCC 1210

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014