Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma

October 22, 2016 updated by: Zhou Zhen, Shanghai Chest Hospital

Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma: a Prospective, Randomized, Open-label, Phase 2 Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

118

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 6 months
Interval from randomization to disease progression, or untolerated toxicity
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response
Time Frame: 2 months
Percentage of complete response and partial response
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Investigators

  • Study Chair: Zhen Zhou, MD, Shanghai Chest Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

October 22, 2016

First Submitted That Met QC Criteria

October 22, 2016

First Posted (ESTIMATE)

October 25, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 22, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chest003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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