Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung

Carcinoma, Non-Small-Cell Lung Clinical Trial

— C-TONG1002  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236716
• Other study ID #: C-TONG1002
• Status: Completed
• Phase: Phase 2
• First received: November 8, 2010
• Last updated: August 4, 2014
• Start date: November 2010
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Chinese Society of Lung Cancer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell
• Lung Neoplasms

Intervention

Drug:
• Albumin paclitaxel plus carboplatin
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.
• Gemcitabine plus carboplatin
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.

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Society of Lung Cancer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate(ORR)	ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks.	18weeks	No
Secondary	Response duration, progression free survival, overall survival, safety profile		2 years	Yes