Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
squamous cell carcinoma of lung, Albumin bound paclitaxel, chemotherapy
Brief summary
This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and some biomarkers is also to be evaluated.
Detailed description
Albumin-bound paclitaxel(nab-P) utilizes the albumin binding proteins,such as (gp60)/caveolin-1 (CAV1) and SPARC(secreted protein acidic and rich in cysteine), achieving high intratumoral paclitaxel accumulation. It is reported that CAV1 is overexpressed in squamous cell cancer(SQC), so it is possible that nab-PC is more highly active than GC in SQC of lung.
Interventions
DRUGAlbumin paclitaxel plus carboplatin
Patients receive carboplatin AUC=5 q3w and nab-p 135 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest.
Patients receive carboplatin AUC=5 q3w and gemcitabine 1250 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest.
Sponsors
Chinese Society of Lung Cancer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Previously untreated, histological documented stage IIIB (not amenable for radical regional therapy) or stage IV squamous cell carcinoma of lung. At least one measurable lesion as defined by RECIST criteria. * At least 18 years of age. * ECOG PS 0\ 1 * Patients have no previously malignant tumor history except cured cervical carcinoma in situ, basal cell carcinoma or superficial bladder cancer. Patients are also eligible if they have received a chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred over 12 months since the finishing of neoadjuvant or adjuvant chemotherapy. * neutrophil ≥ 1.5 x 109 /L, Hemoglobin \> 90 g/L, Platelet count \> 100x109/L. * Total bilirubin ≤ 1.5 x upper limit of normal. ALT and AST \< 2.5 x upper limit of normal without liver metastasis, ALT and AST \< 5 x upper limit of normal with liver metastasis. Serum creatinine \< 1.5 x upper limit of normal. * Urine pregnancy test is negative for woman. * Estimated life expectancy is at least 3 months. * Patient comply with the clinical trial protocal. * Informed consent must be signed.
Exclusion criteria
* Patients who are currently undergoing other anti-tumor therapy. * Patients who was enrolled in any other clinical trial within 4 weeks of study entry. * Any physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication or render the subject at high risk from treatment. * Central nervous system (CNS) tumor or metastatic tumor. * Serious mental disorder. * Serious dysgnosia. * Other serious comorbidity. * Alcohol or drug dependence. * Previously allergic to drugs used in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate(ORR) | 18weeks | ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| Response duration, progression free survival, overall survival, safety profile | 2 years |
Countries
China
Outcome results
None listed