Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung

NCT01236716 | Completed Phase 2 DMC

• 1 other identifier: C-TONG1002
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

squamous cell carcinoma of lung; Albumin bound paclitaxel; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall response rate(ORR)

  ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks.

  18weeks

Secondary Outcomes (1)

• Response duration, progression free survival, overall survival, safety profile

  2 years

Study Arms (2)

Albumin paclitaxel plus carboplatin

EXPERIMENTAL

Treatment of Albumin paclitaxel plus carboplatin

Drug: Albumin paclitaxel plus carboplatin

Gemcitabine plus carboplatin

ACTIVE COMPARATOR

Treatment of Gemcitabine plus carboplatin

Drug: Gemcitabine plus carboplatin

Interventions

Albumin paclitaxel plus carboplatin 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.

Also known as: Abraxane(Albumin-bound paclitaxel,nab-P)

Albumin paclitaxel plus carboplatin

Gemcitabine plus carboplatin 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.

Also known as: Gemzar(Gemcitabine)

Gemcitabine plus carboplatin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Society of Lung Cancer: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Related Publications (3)

• 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.

  PMID: 30739019 DERIVED

• 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.

  PMID: 25239521 DERIVED

• 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.

  PMID: 22461458 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Wu Yilong, professor

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: August 6, 2014

Record last verified: 2014-08

Locations

CN (1)