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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | PFS is evaluated in the 24 months since the treatment began | 24 months |
| overall survival | evaluated in the 24th month since the treatment began |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengxiang Ren | Contact | harry_ren@126.com | ||
| Caicun Zhou | Contact | caicunzhoudr@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Guanghui Gao | Tongji University Affiliated Shanghai Pulmonary Hospital | Study Chair |
| Chunxia Su | Tongji University Affiliated Shanghai Pulmonary Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengxiang Ren | Recruiting | Shanghai | 200433 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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|
| 24 months |
| 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 |
| Quality Of Life | evaluated in the 24th month since the treatment began | 24 months |
| Xiaoxia Chen |
| Tongji University Affiliated Shanghai Pulmonary Hospital |
| Study Chair |
| Wei Li | Tongji University Affiliated Shanghai Pulmonary Hospital | Study Chair |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |