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

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01969955

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Jun 1, 2015

Arms and Interventions

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 Names: Abraxane, nab-paclitaxel

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 Names:

Abraxane, nab-paclitaxel

Outcome Measures

Primary Outcome Measures

Objective response rate [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

progression-free survival [up to 15 months]
Measure of time from study treatment to disease progression or death.
Overall survival [up to 2 years]
Measure of time from study treatment to patient's death or lost to follow-up.
Quality of life [up to 15 months]
Determine the score change of quality of life between pre- and post-treatment.
Safety and tolerability [up to 18 months]
Percentage of patients who experience an adverse event during this study.

Other Outcome Measures

secreted protein acidic and rich in cysteine (SPARC) expression level in tumor issues [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.