Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung (C-TONG1002)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yi-Long Wu, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier:
NCT01236716
First received: November 8, 2010
Last updated: August 4, 2014
Last verified: August 2014
  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 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 ]

Enrollment: 126
Study Start Date: November 2010
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albumin paclitaxel plus carboplatin
Treatment of Albumin paclitaxel plus carboplatin
Drug: 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.
Other Name: Abraxane(Albumin-bound paclitaxel,nab-P)
Active Comparator: Gemcitabine plus carboplatin
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236716

Locations
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
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: Yi-Long Wu, Professor, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier: NCT01236716     History of Changes
Other Study ID Numbers: C-TONG1002
Study First Received: November 8, 2010
Last Updated: August 4, 2014
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, Squamous Cell
Carcinoma, Non-Small-Cell Lung
Carcinoma
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Gemcitabine
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 16, 2014