A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer
Both
Non-small Cell Lung Cancer
Trial Information
A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate
Outcome Time Frame:
one year
Safety Issue:
No
Authority:
South Korea: Institutional Review Board
Study ID:
2011-GIRBA-2351
NCT ID:
NCT01770795
Start Date:
January 2011
Completion Date:
Related Keywords:
- Non-Small Cell Lung Cancer
- non-small cell lung cancer
- gemcitabine
- genexol-PM
- paclitaxel
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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