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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