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

Primary Purpose

Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nab-paclitaxel

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring small cell lung cancer, chemotherapy, Nab-paclitaxel

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shengxiang RenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nab-paclitaxel single agent

Arm Description

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

Outcomes

Primary Outcome Measures

Objective Response Rate

To evaluate Objective response rate every 6-8 weeks after the initiation of chemotherapy and before the completion of chemotherapy

Secondary Outcome Measures

Progression free survival

PFS is evaluated in the 24 months since the treatment began

overall survival

evaluated in the 24th month since the treatment began

Side effects

evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Quality Of Life

evaluated in the 24th month since the treatment began

Full Information

NCT ID

NCT02262897

First Posted

September 23, 2014

Last Updated

October 7, 2014

Sponsor

Tongji University

1. Study Identification

Unique Protocol Identification Number

NCT02262897

Brief Title

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

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tongji University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

Keywords

small cell lung cancer, chemotherapy, Nab-paclitaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nab-paclitaxel single agent

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel

Other Intervention Name(s)

Albumin-bound paclitaxel， Abraxane

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective Response Rate

Description

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

Secondary Outcome Measure Information:

Title

Progression free survival

Description

PFS is evaluated in the 24 months since the treatment began

Time Frame

24 months

Title

overall survival

Description

evaluated in the 24th month since the treatment began

Time Frame

24 months

Title

Side effects

Description

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

Title

Quality Of Life

Description

evaluated in the 24th month since the treatment began

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shengxiang Ren

harry_ren@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Caicun Zhou

caicunzhoudr@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guanghui Gao

Organizational Affiliation

Tongji University Affiliated Shanghai Pulmonary Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Chunxia Su

Organizational Affiliation

Tongji University Affiliated Shanghai Pulmonary Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Xiaoxia Chen

Organizational Affiliation

Tongji University Affiliated Shanghai Pulmonary Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Wei Li

Organizational Affiliation

Tongji University Affiliated Shanghai Pulmonary Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Shengxiang Ren

City

Shanghai

ZIP/Postal Code

200433

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shengxiang Ren

harry_ren@126.com

First Name & Middle Initial & Last Name & Degree

Guanghui Gao

ghgao103@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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