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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Lung Drug: nanoparticle albumin-bound paclitaxel Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: nanoparticle albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: up to 15 months ]
    Measure of time from study treatment to disease progression or death.

  2. Overall survival [ Time Frame: up to 2 years ]
    Measure of time from study treatment to patient's death or lost to follow-up.

  3. Quality of life [ Time Frame: up to 15 months ]
    Determine the score change of quality of life between pre- and post-treatment.

  4. Safety and tolerability [ Time Frame: up to 18 months ]
    Percentage of patients who experience an adverse event during this study.


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969955


Contacts
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Contact: Junling Li 86-13801178891 drlijunling@vip.163.com

Locations
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China, Beijing
Cancer institute and hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Junling Li       drlijunling@vip.163.com   
Principal Investigator: Junling Li         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Junling Li Cancer Institute and Hospital, Chinese Academy of Medical Sciences
More Information
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Responsible Party: LI Junling, Professor and chief physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01969955    
Other Study ID Numbers: CH-L-031
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014
Keywords provided by LI Junling, Chinese Academy of Medical Sciences:
nanoparticle albumin-bound paclitaxel
Squamous Cell Carcinoma of Lung
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action