Clinical trial NCT01969955: Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of Lung
Keywords: nanoparticle albumin-bound paclitaxel
Squamous Cell Carcinoma of Lung
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2013-10-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Objective response rate
timeFrame: up to one year
Secondary outcomes:
measure: progression-free survival
timeFrame: up to 15 months
measure: Overall survival
timeFrame: up to 2 years
measure: Quality of life
timeFrame: up to 15 months
measure: Safety and tolerability
timeFrame: up to 18 months
Other outcomes:
measure: secreted protein acidic and rich in cysteine (SPARC) expression level in tumor issues
timeFrame: up to 15 months
Locations:
city: Beijing
country: China
facility: Cancer institute and hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Junling Li
role: PRINCIPAL_INVESTIGATOR
References: