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

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02262897
• Other study ID #: FK1401
• Status: Recruiting
• Phase: Phase 2
• First received: September 23, 2014
• Last updated: October 7, 2014
• Start date: September 2013
• Est. completion date: May 2016

Study information

• Verified date: October 2014
• Source: Tongji University
• Contact: Shengxiang Ren
• Email: harry_ren[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Shengxiang Ren	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Progression free survival	PFS is evaluated in the 24 months since the treatment began	24 months	No
Secondary	overall survival	evaluated in the 24th month since the treatment began	24 months	No
Secondary	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	No
Secondary	Quality Of Life	evaluated in the 24th month since the treatment began	24 months	No