Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung (C-TONG1002)

Chinese Society of Lung Cancer

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Gemcitabine plus carboplatin

Drug: Albumin paclitaxel plus carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01236716

C-TONG1002

Details and patient eligibility

About

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.

Full 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.

Enrollment

126 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.