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

NCT ID: NCT02262897

Last Updated: 2014-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-05-31

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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nab-paclitaxel single agent

Nab-paclitaxel single agent, either in 130mg/m2 weekly regimen, d1,8,15 every 4 weeks or in 230mg/m2 d1 every 3 weeks

Group Type: EXPERIMENTAL

Nab-paclitaxel

Intervention Type: DRUG

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

Interventions

Nab-paclitaxel

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

Intervention Type: DRUG

Other Intervention Names

Albumin-bound paclitaxel， Abraxane

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji University

OTHER

Sponsor Role: lead

Responsible Party

Caicun Zhou

Shanghai Pulmonary Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guanghui Gao

Role: STUDY_CHAIR

Tongji University Affiliated Shanghai Pulmonary Hospital

Chunxia Su

Role: STUDY_CHAIR

Tongji University Affiliated Shanghai Pulmonary Hospital

Xiaoxia Chen

Role: STUDY_CHAIR

Tongji University Affiliated Shanghai Pulmonary Hospital

Wei Li

Role: STUDY_CHAIR

Tongji University Affiliated Shanghai Pulmonary Hospital

Locations

Shengxiang Ren

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Shengxiang Ren

Role: CONTACT

harry_ren@126.com

Caicun Zhou

Role: CONTACT

caicunzhoudr@126.com

Facility Contacts

Shengxiang Ren

Role: primary

harry_ren@126.com

Guanghui Gao

Role: backup

ghgao103@hotmail.com

Other Identifiers

FK1401

Identifier Type: -

Identifier Source: org_study_id