Patients with extensive disease(ED) small cell lung cancer is still have a dismal prognosis, even though the first line chemotherapy showing about 70% response rate. Most of the patients will relapse with in 6 months after the chemotherapy and the following therapy such as second line chemotherapy have a very limited efficacy to these patients. Currently, there is no standard 3rd line therapy for the patients with ED small cell lung cancer(SCLC). As the investigators know, Nab-paclitaxel had showing promising efficacy in several cases report in the patients with SCLC, the aim of this clinical trial is to investigate the efficacy and safety of nab-paclitaxel as a single agent in the SCLC patients with extensive disease and failed to first line/ second line chemotherapy.
Primary end point: Objective Response Rate(ORR) Secondary end point: Progression Free Survival(PFS), Overall Survival(OS), Side effects according to Common Terminology Criteria for Adverse Events(CTCAE) version 4.0 Quality Of Life(QOL) etc.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Nab-paclitaxel weekly chemotherapy 130mg/m2, d1,8,15,every 4 week or Nab-paclitaxel chemotherapy once a time with a dose of 230 mg/m2 every 3 weeks
Shengxiang Ren
Shanghai, China
RECRUITINGObjective Response Rate
To evaluate Objective response rate every 6-8 weeks after the initiation of chemotherapy and before the completion of chemotherapy
Time frame: tumor assessment every 6-8 weeks after the initiation of chemotherapy, up to 24 months
Progression free survival
PFS is evaluated in the 24 months since the treatment began
Time frame: 24 months
overall survival
evaluated in the 24th month since the treatment began
Time frame: 24 months
Side effects
evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: 24 months
Quality Of Life
evaluated in the 24th month since the treatment began
Time frame: 24 months
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