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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770795
• Other study ID #: 2011-GIRBA-2351
• Status: Completed
• Phase: Phase 2
• First received: January 16, 2013
• Last updated: January 16, 2013
• Start date: January 2011

Study information

• Verified date: January 2013
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Genexol-PM/Gemcitabine

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		one year	No
Secondary	progression free survival		one year	No
Secondary	overall survival		one year	No
Secondary	toxicities		one year	Yes