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Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02943798
Recruitment Status : Unknown
Verified October 2016 by Zhou Zhen, Shanghai Chest Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 25, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Zhou Zhen, Shanghai Chest Hospital

Brief Summary:
The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma.

Condition or disease Intervention/treatment Phase
Pulmonary Large Cell Neuroendocrine Carcinoma Drug: etoposide plus carboplatin Drug: Paclitaxel plus carboplatin Phase 2

Detailed Description:

The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma.

In addition, gene spectrum detection and Mini-PDX are applied for validation of pharmacodynamic.

Results of clinical trials and pharmacodynamic test will be analyzed to provide evidence for the precise treatment for LCNEC.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma: a Prospective, Randomized, Open-label, Phase 2 Study
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Group A
Patients will be administered with etoposide plus carboplatin as first-line treatment.
Drug: etoposide plus carboplatin
etoposide is administered by venus with a dose of 100mg/m2 from day 1 to3, and carboplatin is administered by venus with a dose of AUC 5 on day 1 in a 21-day cycle.
Other Name: VP-16

Experimental: Group B
Patients will be administered with paclitaxel plus carboplatin as first-line treatment.
Drug: Paclitaxel plus carboplatin
Paclitaxel is administered by venus with a dose of 175 mg/m2 from day 1 and carboplatin is administered by venus with a dose of AUC 5 on day 1 in a 21-day cycle.
Other Name: Taxol




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 6 months ]
    Interval from randomization to disease progression, or untolerated toxicity


Secondary Outcome Measures :
  1. Tumor response [ Time Frame: 2 months ]
    Percentage of complete response and partial response



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage IIIB or IV pulmonary large-cell neuroendocrine carcinoma confirmed by histology or cytology
  • Estimated life expectancy over 3 months
  • Performance status 0,1,2
  • Signed informed consent
  • Adequate organ functions: absolute neutrophil count (ANC) over 1,500 cells/mm3 (1.5 x 109/L); platelet count over100,000/mm3 (100 x 109/L); serum creatinine < 2.5 mg/dL (221 mmol/L); serum AST or ALT <5.0 x upper limit of normal (ULN); serum total bilirubin <2.0 mg/dL (34 mmol/L)

Exclusion Criteria:

  • History of chemotherapy or molecular targeted therapy
  • Thoracic radical radiotherapy within 28 days of the initiation of study drug therapy except for palliative radiotherapy
  • Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy
  • Prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for > or = to 1 year
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Pregnant or lactating
  • Patient with concurrent medical or psychiatric illness which would, in the opinion of the investigator, prevent compliance with the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943798


Contacts
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Contact: Zhen Zhou, MD jenniferzhou1116@163.com

Sponsors and Collaborators
Shanghai Chest Hospital
Investigators
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Study Chair: Zhen Zhou, MD Shanghai Chest Hospital

Publications of Results:
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Responsible Party: Zhou Zhen, Chief Physician, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT02943798    
Other Study ID Numbers: Chest003
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zhou Zhen, Shanghai Chest Hospital:
Pulmonary Large Cell Neuroendocrine Carcinoma,chemotherapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Paclitaxel
Etoposide
Albumin-Bound Paclitaxel
Carboplatin
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors