Clinical trial NCT01236716: Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: squamous cell carcinoma of lung
Albumin bound paclitaxel
chemotherapy
Lead sponsor: Chinese Society of Lung Cancer
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall response rate(ORR)
timeFrame: 18weeks
Secondary outcomes:
measure: Response duration, progression free survival, overall survival, safety profile
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Wu Yilong, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.