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

Phase 2

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Genexol-PM/Gemcitabine

• Registration Number: NCT01770795
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-10
• Status Verified: 2013-01
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-16
• Last Update Submitted: 2013-01-16
• Study First Posted: 2013-01-18
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Genexol-PM/Gemcitabine	Genexol-PM/Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Overall response rate	one year

Secondary Outcome Measures

Name	Time	Method
progression free survival	one year
overall survival	one year
toxicities	one year

Trial Locations

Locations (1)

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of