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

August 4, 2014 updated by: Yi-Long Wu, Chinese Society of Lung Cancer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Gemzar(Gemcitabine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate(ORR)
Time Frame: 18weeks
ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks.
18weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Response duration, progression free survival, overall survival, safety profile
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Society of Lung Cancer

Investigators

  • Principal Investigator: Wu Yilong, professor, Guangdong Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (Estimate)

November 9, 2010

Study Record Updates

Last Update Posted (Estimate)

August 6, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-TONG1002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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