Status:
UNKNOWN
The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer
Lead Sponsor:
Tongji University
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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(CT...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02262897
Start Date
September 1 2013
End Date
May 1 2016
Last Update
October 13 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shengxiang Ren
Shanghai, China, 200433