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
ClinicalTrials.gov 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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: one year ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]
  • toxicities [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01770795

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

No publications provided

Responsible Party: Eun Kyung Cho, Professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01770795     History of Changes
Other Study ID Numbers: 2011-GIRBA-2351 
Study First Received: January 16, 2013
Last Updated: January 16, 2013
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 10, 2016