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Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer

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ClinicalTrials.gov Identifier: NCT01969955
Recruitment Status : Unknown
Verified April 2014 by LI Junling, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : October 25, 2013
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
LI Junling, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE October 22, 2013
First Posted Date  ICMJE October 25, 2013
Last Update Posted Date April 25, 2014
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2013)
Objective response rate [ Time Frame: up to one year ]
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2013)
  • progression-free survival [ Time Frame: up to 15 months ]
    Measure of time from study treatment to disease progression or death.
  • Overall survival [ Time Frame: up to 2 years ]
    Measure of time from study treatment to patient's death or lost to follow-up.
  • Quality of life [ Time Frame: up to 15 months ]
    Determine the score change of quality of life between pre- and post-treatment.
  • Safety and tolerability [ Time Frame: up to 18 months ]
    Percentage of patients who experience an adverse event during this study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 14, 2013)
secreted protein acidic and rich in cysteine (SPARC) expression level in tumor issues [ Time Frame: up to 15 months ]
Correlationship between secreted protein acidic and rich in cysteine (SPARC) expression in tumor issue and the efficacy of nab-paclitaxel or prognosis of patients
Original Other Pre-specified Outcome Measures
 (submitted: October 22, 2013)
secreted protein acidic and rich in cysteine (SPARC) expression level in tumor issues [ Time Frame: up to 15 months ]
Corelationship between secreted protein acidic and rich in cysteine (SPARC) expression in tumor issue and the efficacy of nab-paclitacel or prognosis of patients
 
Descriptive Information
Brief Title  ICMJE Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of Lung
Intervention  ICMJE Drug: nanoparticle albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.
Other Name: Abraxane, nab-paclitaxel
Study Arms  ICMJE Experimental: nanoparticle albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.
Intervention: Drug: nanoparticle albumin-bound paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 22, 2013)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed-consent form;
  2. Age no less than 18 years;
  3. Histologically confirmed locally advanced or metastatic squamous lung cancer;
  4. Eastern Cooperative Oncology Group (ECOG) 0-2 with life expectation of no less than 12 weeks;
  5. RECIST measurable lesions;
  6. Disease progression after failure of platinum-based doublet therapy;
  7. Adequate liver/renal/bone marrow function;
  8. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measures until 3 months after study end;
  9. Compliance, and can be followed up regularly.

Exclusion Criteria:

  1. Pregnant or breast-feeding female, or not willing to take contraception measures during study;
  2. Radiotherapy within 30 days, systematic therapy within 21 days;
  3. Serious infection requiring antibiotics intervention during recruitment;
  4. Allergic to study drug;
  5. Require concurrent biological target therapy;
  6. More than grade 1 neuropathy;
  7. Uncontrolled brain metastasis or mental illness;
  8. Congestive heart failure, uncontrolled cardiac arrhythmia, etc;
  9. Other malignancy within 5 years;
  10. Can't be followed up or obey protocol;
  11. Ineligible by the judge of the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01969955
Other Study ID Numbers  ICMJE CH-L-031
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LI Junling, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Junling Li Cancer Institute and Hospital, Chinese Academy of Medical Sciences
PRS Account Chinese Academy of Medical Sciences
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP