Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Society of Lung Cancer
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Gemcitabine; Paclitaxel

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.