The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Conditions
THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: gemcitabine
Type: Drug
Overall Status
Recruiting
Summary
assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Cancer hospital Fudan University
Shanghai, Shanghai, China
Status: Recruiting
Contact: Chang jian hua, MD,PHD - 13916619284 - changjianhua@163.com
Start Date
August 2008
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page