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

Phase 2

• Conditions: Squamous Cell Carcinoma of Lung
• Interventions: Drug: nanoparticle albumin-bound paclitaxel

• Registration Number: NCT01969955
• Lead Sponsor: Chinese Academy of Medical Sciences

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-25
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-25
• Primary Completion: 2014-12
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Quality of life	up to 15 months	Determine the score change of quality of life between pre- and post-treatment.
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.
Safety and tolerability	up to 18 months	Percentage of patients who experience an adverse event during this study.

Trial Locations

Locations (1)

Cancer institute and hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China