The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Nab-paclitaxel as a Single Agent in the Small Cell Lung Cancer Patients With Extensive Disease and Failed to First Line/ Second Line Chemotherapy

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Nab-paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obtain of informed consent. Male or female aged 18 years and over. Histologically or cytologically confirmed small cell lung carcinoma. Extensive disease before receive nab-paclitaxel. Failed to previous chemotherapy, but the previous paclitaxel chemotherapy is not allowed. World Health Organization (WHO) performance status (PS) of 0 to 2. Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study. Heart index values is in the range, as defined below, within two weeks of randomization: Absolute neutrophils count(ANC)≥2.0×109/L Platelets≥100×109/L Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase (ALT) ≤2.5×ULN(≤5×ULN if liver metastases) Creatinine clearance≥60ml/min Measurable disease according to Response Evaluation Criteria in Solid Tumors(RECIST) criteria with at least one measurable lesion not previously irradiated. Life expectancy ≥12 weeks. Exclusion Criteria: As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease). Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation. Known severe hypersensitivity to nab-paclitaxel or any of the excipients of these products.Known severe hypersensitivity to pre-medications required for treatment with nab-paclitaxel doublet chemotherapy. Prior treatment with paclitaxel. Pregnant or lactating woman. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. Life expectancy of less than 12 weeks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nab-paclitaxel single agent<br>Nab-paclitaxel single agent, either in 130mg/m2 weekly regimen, d1,8,15 every 4 weeks or in 230mg/m2 d1 every 3 weeks | Drug: Nab-paclitaxel<br>* 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<br>* Other names: Albumin-bound paclitaxel， Abraxane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | To evaluate Objective response rate every 6-8 weeks after the initiation of chemotherapy and before the completion of chemotherapy | tumor assessment every 6-8 weeks after the initiation of chemotherapy, up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | PFS is evaluated in the 24 months since the treatment began | 24 months | 
| overall survival | evaluated in the 24th month since the treatment began | 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 | 24 months | 
| Quality Of Life | evaluated in the 24th month since the treatment began | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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small cell lung cancer, chemotherapy, Nab-paclitaxel