The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

Overview

assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2015

Interventions

  • Drug: gemcitabine
    • gemcitabine,1000mg/m2,ivgtt,DAY1&DAY8

Arms, Groups and Cohorts

  • Experimental: gemcitabine

Clinical Trial Outcome Measures

Primary Measures

  • PFS
    • Time Frame: from the first cycle of treatment (day one) to two month after the last cycle

Participating in This Clinical Trial

Inclusion Criteria

18~75 years Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer patients who have acceptted combination chemotherapy based on platinum 4 course,SD OR PR,the CR patients should accept 6 course of combination chemotherapy. 3~8 weeks after patients complete first line chemotherapy(include radiotherapy) Ecog0-2 Expected life time longer than 3 monthes Normal laboratory values:

  • leucocyte ≥ 4×109/L – neutrophil ≥ 1.5×109/L – platelet ≥ 100×109/L – Hemoglobin ≥ 10g/L – ALT and – AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) Signed written informed consent Exclusion Criteria:

  • Patients have used drugs according to protocol – Uncontrolled infection of Bacterial or virus or fungal – Patients with other malignant tumor – Uncontrolled brain metastases – Female patients during their pregnant and lactation period, or patients without contracep

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chang Jian Hua, Vice director of department of chemotherapy – Fudan University

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