Clinical trial NCT02262897: The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: small cell lung cancer
chemotherapy
Nab-paclitaxel
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Obtain of informed consent.
2. Male or female aged 18 years and over.
3. Histologically or cytologically confirmed small cell lung carcinoma.
4. Extensive disease before receive nab-paclitaxel.
5. Failed to previous chemotherapy, but the previous paclitaxel chemotherapy is not allowed.
6. World Health Organization (WHO) performance status (PS) of 0 to 2.
7. 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.
8. 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
9. Measurable disease according to Response Evaluation Criteria in Solid Tumors(RECIST) criteria with at least one measurable lesion not previously irradiated.
10. Life expectancy ≥12 weeks.

Exclusion Criteria:

1. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
2. Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
3. 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.
4. Prior treatment with paclitaxel.
5. Pregnant or lactating woman.
6. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
7. Life expectancy of less than 12 weeks.

Primary outcomes:
measure: Objective Response Rate
timeFrame: tumor assessment every 6-8 weeks after the initiation of chemotherapy, up to 24 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 24 months
measure: overall survival
timeFrame: 24 months
measure: Side effects
timeFrame: 24 months
measure: Quality Of Life
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shengxiang Ren
Study officials:
affiliation: Tongji University Affiliated Shanghai Pulmonary Hospital
name: Guanghui Gao
role: STUDY_CHAIR
affiliation: Tongji University Affiliated Shanghai Pulmonary Hospital
name: Chunxia Su
role: STUDY_CHAIR
affiliation: Tongji University Affiliated Shanghai Pulmonary Hospital
name: Xiaoxia Chen
role: STUDY_CHAIR
affiliation: Tongji University Affiliated Shanghai Pulmonary Hospital
name: Wei Li
role: STUDY_CHAIR
References: