Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Albumin paclitaxel plus carboplatin; Drug: Gemcitabine plus carboplatin

• Registration Number: NCT01236716
• Lead Sponsor: Chinese Society of Lung Cancer

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albumin paclitaxel plus carboplatin	Albumin paclitaxel plus carboplatin	Treatment of Albumin paclitaxel plus carboplatin
Gemcitabine plus carboplatin	Gemcitabine plus carboplatin	Treatment of Gemcitabine plus carboplatin

Primary Outcome Measures

Name	Time	Method
Overall response rate(ORR)	18weeks	ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks.

Secondary Outcome Measures

Name	Time	Method
Response duration, progression free survival, overall survival, safety profile	2 years

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China