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

Overview

The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2014

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.

Interventions

  • Drug: nanoparticle albumin-bound paclitaxel
    • Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese Academy of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: LI Junling, Professor and chief physician – Chinese Academy of Medical Sciences
  • Overall Official(s)
    • Junling Li, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Overall Contact(s)
    • Junling Li, 86-13801178891, drlijunling@vip.163.com

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