Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung (C-TONG1002)
This study is not yet open for participant recruitment.
Verified November 2010 by Chinese Society of Lung Cancer
Sponsor:
Chinese Society of Lung Cancer
Information provided by:
Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier:
NCT01236716
First received: November 8, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: Albumin-bound paclitaxel plus carboplatin Drug: Gemcitabine plus carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Chinese Society of Lung Cancer:
Primary Outcome Measures:
- Overall response rate(ORR) [ Time Frame: 18weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: nab-PC
Treatment of Albumin-bound paclitaxel(nab-P) plus carboplatin
|
Drug: Albumin-bound 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.
Other Name: Abraxane(Albumin-bound paclitaxel,nab-P)
|
|
Active Comparator: GC
Treatment of Gemcitabine plus carboplatin
|
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.
Other Name: Gemzar(Gemcitabine)
|
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| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236716
Contacts
| Contact: Ben Xiaosong, doctor | 86-20-83827812 ext 61120 | benxs@163.com |
| Contact: Wu Yilong, professor | 86-20-83877855 | syylwu@live.cn |
Locations
| China, Guangdong | |
| Guangdong General Hospital | Not yet recruiting |
| Guangzhou, Guangdong, China, 510080 | |
| Contact: Ben Xiaosong, doctor 86-20-83827812 ext 61120 benxs@163.com | |
| Contact: Wu Yilong, professor 86-20-83877855 syylwu@live.cn | |
| Sub-Investigator: Ben Xiaosong, doctor | |
Sponsors and Collaborators
Chinese Society of Lung Cancer
Investigators
| Principal Investigator: | Wu Yilong, professor | Guangdong General Hospital |
More Information
No publications provided by Chinese Society of Lung Cancer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chinese Thoracic Oncology Group(C-TONG), Guangdong General Hospital, Guangdong Academy of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01236716 History of Changes |
| Other Study ID Numbers: | C-TONG1002 |
| Study First Received: | November 8, 2010 |
| Last Updated: | November 8, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Chinese Society of Lung Cancer:
|
squamous cell carcinoma of lung Albumin bound paclitaxel chemotherapy |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Neoplasms, Squamous Cell |
Gemcitabine Carboplatin Paclitaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013