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

January 16, 2013 updated by: Eun Kyung Cho, Gachon University Gil Medical Center
To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated paclitaxel)and gemcitabine in untreated metastatic NSCLC patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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 Locations

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Genexol-PM/Gemcitabine
Drug: Genexol-PM/Gemcitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: one year
one year
progression free survival
Time Frame: one year
one year
toxicities
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Gachon University Gil Medical Center

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

January 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-GIRBA-2351

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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