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

This study has been completed.
Information provided by (Responsible Party):
Eun Kyung Cho, Gachon University Gil Medical Center Identifier:
First received: January 16, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated paclitaxel)and gemcitabine in untreated metastatic NSCLC patients

Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Genexol-PM/Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: one year ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: one year ]
  • overall survival [ Time Frame: one year ]
  • toxicities [ Time Frame: one year ]

Enrollment: 45
Study Start Date: January 2011
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Genexol-PM/Gemcitabine Drug: Genexol-PM/Gemcitabine


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01770795

Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

Responsible Party: Eun Kyung Cho, Professor, Gachon University Gil Medical Center Identifier: NCT01770795     History of Changes
Other Study ID Numbers: 2011-GIRBA-2351
Study First Received: January 16, 2013
Last Updated: January 16, 2013

Keywords provided by Gachon University Gil Medical Center:
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017