Squamous Cell Carcinoma of Lung
Conditions
Keywords
nanoparticle albumin-bound paclitaxel, Squamous Cell Carcinoma of Lung
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.
Interventions
Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactJunling Li
Outcome results
None listed