Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung

NCT ID: NCT01236716

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-06-30

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Albumin paclitaxel plus carboplatin

Treatment of Albumin paclitaxel plus carboplatin

Group Type: EXPERIMENTAL

Albumin paclitaxel plus carboplatin

Intervention Type: DRUG

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

Treatment of Gemcitabine plus carboplatin

Group Type: ACTIVE_COMPARATOR

Gemcitabine plus carboplatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Abraxane(Albumin-bound paclitaxel,nab-P); Gemzar(Gemcitabine)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Society of Lung Cancer

OTHER

Sponsor Role: lead

Responsible Party

Yi-Long Wu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wu Yilong, professor

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

Guangdong General Hospital

Guangzhou, Guangdong, China

Countries

China

References

Wang Z, Huang C, Yang JJ, Song Y, Cheng Y, Chen GY, Yan HH, Ben XS, Wang BC, Xu CR, Jiang BY, Zhou Q, Chen HJ, Wu YL. A randomised phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in advanced squamous cell lung carcinoma (C-TONG1002). Eur J Cancer. 2019 Mar;109:183-191. doi: 10.1016/j.ejca.2019.01.007. Epub 2019 Feb 7.

Reference Type: DERIVED

PMID: 30739019 (View on PubMed)

Yang JJ, Huang C, Chen GY, Song Y, Cheng Y, Yan HH, Zhou Q, Wu YL. A randomized phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in locally advanced or metastatic squamous cell carcinoma of lung. BMC Cancer. 2014 Sep 20;14:684. doi: 10.1186/1471-2407-14-684.

Reference Type: DERIVED

PMID: 25239521 (View on PubMed)

Gold KA, Wistuba II, Kim ES. New strategies in squamous cell carcinoma of the lung: identification of tumor drivers to personalize therapy. Clin Cancer Res. 2012 Jun 1;18(11):3002-7. doi: 10.1158/1078-0432.CCR-11-2055. Epub 2012 Mar 29.

Reference Type: DERIVED

PMID: 22461458 (View on PubMed)

Other Identifiers

C-TONG1002

Identifier Type: -

Identifier Source: org_study_id