Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma

NCT02943798 | Unknown Phase 2

• 1 other identifier: Chest003
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Large Cell Neuroendocrine Carcinoma

Keywords

Pulmonary Large Cell Neuroendocrine Carcinoma,chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Interval from randomization to disease progression, or untolerated toxicity

  6 months

Secondary Outcomes (1)

• Tumor response

  2 months

Study Arms (2)

Group A

EXPERIMENTAL

Patients will be administered with etoposide plus carboplatin as first-line treatment.

Drug: etoposide plus carboplatin

Group B

EXPERIMENTAL

Patients will be administered with paclitaxel plus carboplatin as first-line treatment.

Drug: Paclitaxel plus carboplatin

Interventions

etoposide plus carboplatin DRUG

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.

Also known as: VP-16

Group A

Paclitaxel plus carboplatin DRUG

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.

Also known as: Taxol

Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Related Publications (1)

• Fasano M, Della Corte CM, Papaccio F, Ciardiello F, Morgillo F. Pulmonary Large-Cell Neuroendocrine Carcinoma: From Epidemiology to Therapy. J Thorac Oncol. 2015 Aug;10(8):1133-41. doi: 10.1097/JTO.0000000000000589.

  PMID: 26039012 RESULT

MeSH Terms

Interventions

Etoposide; Carboplatin; Paclitaxel

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Zhen Zhou, MD

  Shanghai Chest Hospital

  STUDY CHAIR

Central Study Contacts

Zhen Zhou, MD

CONTACT

jenniferzhou1116@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 22, 2016
• First Posted: October 25, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 25, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share