Back to resultsNab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer
Primary Purpose
Squamous Cell Carcinoma of Lung
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nanoparticle albumin-bound paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of Lung focused on measuring nanoparticle albumin-bound paclitaxel, Squamous Cell Carcinoma of Lung
Eligibility Criteria
Inclusion Criteria:
- Signed informed-consent form;
- Age no less than 18 years;
- Histologically confirmed locally advanced or metastatic squamous lung cancer;
- Eastern Cooperative Oncology Group (ECOG) 0-2 with life expectation of no less than 12 weeks;
- RECIST measurable lesions;
- Disease progression after failure of platinum-based doublet therapy;
- Adequate liver/renal/bone marrow function;
- Human Chorionic Gonadotropin (HCG) test negative for female with contraception measures until 3 months after study end;
- Compliance, and can be followed up regularly.
Exclusion Criteria:
- Pregnant or breast-feeding female, or not willing to take contraception measures during study;
- Radiotherapy within 30 days, systematic therapy within 21 days;
- Serious infection requiring antibiotics intervention during recruitment;
- Allergic to study drug;
- Require concurrent biological target therapy;
- More than grade 1 neuropathy;
- Uncontrolled brain metastasis or mental illness;
- Congestive heart failure, uncontrolled cardiac arrhythmia, etc;
- Other malignancy within 5 years;
- Can't be followed up or obey protocol;
- Ineligible by the judge of the investigator.
Sites / Locations
- Cancer institute and hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nanoparticle albumin-bound paclitaxel
Arm Description
Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.
Outcomes
Primary Outcome Measures
Objective response rate
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
Secondary Outcome Measures
progression-free survival
Measure of time from study treatment to disease progression or death.
Overall survival
Measure of time from study treatment to patient's death or lost to follow-up.
Quality of life
Determine the score change of quality of life between pre- and post-treatment.
Safety and tolerability
Percentage of patients who experience an adverse event during this study.
Full Information
NCT ID
NCT01969955
First Posted
October 22, 2013
Last Updated
April 24, 2014
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01969955
Brief Title
Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer
Official Title
A Phase II Trial of Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer After Failure of Platinum Doublet (Except Pemetrexed) Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer.
Detailed Description
Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel, solvent-free, albumin-bound nanoparticle form of paclitaxel designed to avoid problems associated with solvents used in Taxol. And albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy, and with greater concentration in tumor tissue compared with normal tissues. A multicenter randomized controled trial (coded as CA031) showed that nab-paclitaxel in combination with carboplatin had higher response rate than traditional paclitaxel plus carboplatin, especially in squamous lung cancer. This is a single center, non-randomized, open-label Phase II clinical study to investigate the efficacy and tolerability of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer after failure of platinum-based doublet therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Lung
Keywords
nanoparticle albumin-bound paclitaxel, Squamous Cell Carcinoma of Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nanoparticle albumin-bound paclitaxel
Arm Type
Experimental
Arm Description
Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.
Intervention Type
Drug
Intervention Name(s)
nanoparticle albumin-bound paclitaxel
Other Intervention Name(s)
Abraxane, nab-paclitaxel
Intervention Description
Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.
Primary Outcome Measure Information:
Title
Objective response rate
Description
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
progression-free survival
Description
Measure of time from study treatment to disease progression or death.
Time Frame
up to 15 months
Title
Overall survival
Description
Measure of time from study treatment to patient's death or lost to follow-up.
Time Frame
up to 2 years
Title
Quality of life
Description
Determine the score change of quality of life between pre- and post-treatment.
Time Frame
up to 15 months
Title
Safety and tolerability
Description
Percentage of patients who experience an adverse event during this study.
Time Frame
up to 18 months
Other Pre-specified Outcome Measures:
Title
secreted protein acidic and rich in cysteine (SPARC) expression level in tumor issues
Description
Correlationship between secreted protein acidic and rich in cysteine (SPARC) expression in tumor issue and the efficacy of nab-paclitaxel or prognosis of patients
Time Frame
up to 15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed-consent form;
Age no less than 18 years;
Histologically confirmed locally advanced or metastatic squamous lung cancer;
Eastern Cooperative Oncology Group (ECOG) 0-2 with life expectation of no less than 12 weeks;
RECIST measurable lesions;
Disease progression after failure of platinum-based doublet therapy;
Adequate liver/renal/bone marrow function;
Human Chorionic Gonadotropin (HCG) test negative for female with contraception measures until 3 months after study end;
Compliance, and can be followed up regularly.
Exclusion Criteria:
Pregnant or breast-feeding female, or not willing to take contraception measures during study;
Radiotherapy within 30 days, systematic therapy within 21 days;
Serious infection requiring antibiotics intervention during recruitment;
Allergic to study drug;
Require concurrent biological target therapy;
More than grade 1 neuropathy;
Uncontrolled brain metastasis or mental illness;
Congestive heart failure, uncontrolled cardiac arrhythmia, etc;
Other malignancy within 5 years;
Can't be followed up or obey protocol;
Ineligible by the judge of the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junling Li
Phone
86-13801178891
Email
drlijunling@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junling Li
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer institute and hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junling Li
Email
drlijunling@vip.163.com
First Name & Middle Initial & Last Name & Degree
Junling Li
12. IPD Sharing Statement
Learn more about this trial
Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer
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