Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung (C-TONG1002)
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Albumin paclitaxel plus carboplatin
Gemcitabine plus carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring squamous cell carcinoma of lung, Albumin bound paclitaxel, chemotherapy
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.
Sites / Locations
- Guangdong General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Albumin paclitaxel plus carboplatin
Gemcitabine plus carboplatin
Arm Description
Treatment of Albumin paclitaxel plus carboplatin
Treatment of Gemcitabine plus carboplatin
Outcomes
Primary Outcome Measures
Overall response rate(ORR)
ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks.
Secondary Outcome Measures
Response duration, progression free survival, overall survival, safety profile
Full Information
NCT ID
NCT01236716
First Posted
November 8, 2010
Last Updated
August 4, 2014
Sponsor
Chinese Society of Lung Cancer
1. Study Identification
Unique Protocol Identification Number
NCT01236716
Brief Title
Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Society of Lung Cancer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
squamous cell carcinoma of lung, Albumin bound paclitaxel, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Albumin paclitaxel plus carboplatin
Arm Type
Experimental
Arm Description
Treatment of Albumin paclitaxel plus carboplatin
Arm Title
Gemcitabine plus carboplatin
Arm Type
Active Comparator
Arm Description
Treatment of Gemcitabine plus carboplatin
Intervention Type
Drug
Intervention Name(s)
Albumin paclitaxel plus carboplatin
Other Intervention Name(s)
Abraxane(Albumin-bound paclitaxel,nab-P)
Intervention Description
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
Intervention Name(s)
Gemcitabine plus carboplatin
Other Intervention Name(s)
Gemzar(Gemcitabine)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall response rate(ORR)
Description
ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks.
Time Frame
18weeks
Secondary Outcome Measure Information:
Title
Response duration, progression free survival, overall survival, safety profile
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu Yilong, professor
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
30739019
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.
Results Reference
derived
PubMed Identifier
25239521
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.
Results Reference
derived
PubMed Identifier
22461458
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. Erratum In: Clin Cancer Res. 2012 Aug 1;18(15):4215.
Results Reference
derived
Learn more about this trial
Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung
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