Status:
COMPLETED
Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung
Lead Sponsor:
Chinese Society of Lung Cancer
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 als...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01236716
Start Date
November 1 2010
End Date
June 1 2014
Last Update
August 6 2014
Active Locations (1)
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1
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080