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

NCT02262897 | Unknown Phase 2 DMC

• 1 other identifier: FK1401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer; chemotherapy; Nab-paclitaxel

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Progression free survival

  24 months

• overall survival

  24 months

• Side effects

  24 months

• Quality Of Life

  24 months

Study Arms (1)

Nab-paclitaxel single agent

EXPERIMENTAL

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

Drug: Nab-paclitaxel

Interventions

Nab-paclitaxel 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

Also known as: Albumin-bound paclitaxel， Abraxane

Nab-paclitaxel single agent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Shengxiang Ren

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Guanghui Gao

  Tongji University Affiliated Shanghai Pulmonary Hospital

  STUDY CHAIR

• Chunxia Su

  Tongji University Affiliated Shanghai Pulmonary Hospital

  STUDY CHAIR

• Xiaoxia Chen

  Tongji University Affiliated Shanghai Pulmonary Hospital

  STUDY CHAIR

• Wei Li

  Tongji University Affiliated Shanghai Pulmonary Hospital

  STUDY CHAIR

Central Study Contacts

Shengxiang Ren

CONTACT

harry_ren@126.com

Caicun Zhou

CONTACT

caicunzhoudr@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai Pulmonary Hospital

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: October 13, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: October 13, 2014

Record last verified: 2014-10

Locations

CN (1)