Skip to main content
OpenTrials
Completed

NCT Number: NCT01236716

Nab-Paclitaxel Treatment 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Abraxane(Albumin-bound paclitaxel,nab-P)

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.

Other names: Gemzar(Gemcitabine)

Primary outcomes

  1. Overall response rate(ORR)

    Time frame: 18weeks

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

Secondary outcomes

  1. Response duration, progression free survival, overall survival, safety profile

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Chinese Society of Lung Cancer

Other

Registry information

Official study 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

Acronym: C-TONG1002

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Nov 9, 2010
Registry last updated
Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.