Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung

Last updated: August 4, 2014
Sponsor: Chinese Society of Lung Cancer
Overall Status: Completed

Phase

2

Condition

Carcinoma

Lung Cancer

Treatment

N/A

Clinical Study ID

NCT01236716
C-TONG1002
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Previously untreated, histological documented stage IIIB (not amenable for radicalregional therapy) or stage IV squamous cell carcinoma of lung. At least one measurablelesion 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 insitu, basal cell carcinoma or superficial bladder cancer. Patients are also eligibleif they have received a chemotherapy regimen as neoadjuvant or adjuvant chemotherapyand the disease recurred over 12 months since the finishing of neoadjuvant or adjuvantchemotherapy.

  • 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 ofnormal without liver metastasis, ALT and AST < 5 x upper limit of normal with livermetastasis. 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

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 reasonablesuspicion of a disease or condition that contraindicates the use of any studymedication 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 Design

Total Participants: 126
Study Start date:
November 01, 2010
Estimated Completion Date:
June 30, 2014

Study 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.

Connect with a study center

  • Guangdong General Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

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