Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung

Study Overview
=================
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.

Official Title
-----------------
A Randomized Phase II Clinical Trial of Nab-Paclitaxel and Carboplatin Compared With Gemcitabine and Carboplatin as First-line Therapy in Advanced Squamous Cell Carcinoma of Lung

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: Albumin paclitaxel plus carboplatin
* Drug: Gemcitabine plus carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albumin paclitaxel plus carboplatin<br>Treatment of Albumin paclitaxel plus carboplatin | Drug: Albumin paclitaxel plus carboplatin<br>* 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.<br>* Other names: Abraxane(Albumin-bound paclitaxel,nab-P);|
| Active Comparator: Gemcitabine plus carboplatin<br>Treatment of Gemcitabine plus carboplatin | Drug: Gemcitabine plus carboplatin<br>* 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.<br>* Other names: Gemzar(Gemcitabine);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate(ORR) | ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks. | 18weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response duration, progression free survival, overall survival, safety profile |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
squamous cell carcinoma of lung, Albumin bound paclitaxel, chemotherapy