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

Squamous Cell Carcinoma of Lung Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01969955
• Other study ID #: CH-L-031
• Status: Recruiting
• Phase: Phase 2
• First received: October 22, 2013
• Last updated: April 24, 2014
• Start date: September 2013
• Est. completion date: June 2015

Study information

• Verified date: April 2014
• Source: Chinese Academy of Medical Sciences
• Contact: Junling Li
• Phone: 86-13801178891
• Email: drlijunling[@]vip.163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Lung Neoplasms
• Squamous Cell Carcinoma of Lung

Intervention

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

Locations

Country	Name	City	State
China	Cancer institute and hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	secreted protein acidic and rich in cysteine (SPARC) expression level in tumor issues	Correlationship between secreted protein acidic and rich in cysteine (SPARC) expression in tumor issue and the efficacy of nab-paclitaxel or prognosis of patients	up to 15 months	No
Primary	Objective response rate	Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).	up to one year	No
Secondary	progression-free survival	Measure of time from study treatment to disease progression or death.	up to 15 months	No
Secondary	Overall survival	Measure of time from study treatment to patient's death or lost to follow-up.	up to 2 years	No
Secondary	Quality of life	Determine the score change of quality of life between pre- and post-treatment.	up to 15 months	No
Secondary	Safety and tolerability	Percentage of patients who experience an adverse event during this study.	up to 18 months	Yes