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A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Genexol-PM/Gemcitabine
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring non-small cell lung cancer, gemcitabine, genexol-PM, paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age over 18
  • histologically or cytologically confirmted non-small cell lung cancer
  • stage IIIb with pleural effusion or stage IV
  • ECOG PS 0-2
  • at least one measurable lesion
  • expected life span more than 3 months
  • normal bone marrow, liver, renal function
  • no prior chemotherapy or radiotherapy except for whole brain radiotherapy for symptomatic brain metastases
  • more than 6 months from the last adjuvant chemotherapy

Exclusion Criteria:

  • active infection
  • severe comorbitidies
  • pregnant or lactating women
  • other invasive malignancies
  • poorly controlled symptomatic brain metastases

Sites / Locations

  • Gachon University Gil Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Genexol-PM/Gemcitabine

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

progression free survival
overall survival
toxicities

Full Information

First Posted
January 16, 2013
Last Updated
January 16, 2013
Sponsor
Gachon University Gil Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01770795
Brief Title
A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer
Official Title
A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center

4. Oversight

5. Study Description

Brief Summary
To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated paclitaxel)and gemcitabine in untreated metastatic NSCLC patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
non-small cell lung cancer, gemcitabine, genexol-PM, paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genexol-PM/Gemcitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Genexol-PM/Gemcitabine
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
one year
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
one year
Title
overall survival
Time Frame
one year
Title
toxicities
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age over 18 histologically or cytologically confirmted non-small cell lung cancer stage IIIb with pleural effusion or stage IV ECOG PS 0-2 at least one measurable lesion expected life span more than 3 months normal bone marrow, liver, renal function no prior chemotherapy or radiotherapy except for whole brain radiotherapy for symptomatic brain metastases more than 6 months from the last adjuvant chemotherapy Exclusion Criteria: active infection severe comorbitidies pregnant or lactating women other invasive malignancies poorly controlled symptomatic brain metastases
Facility Information:
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer

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