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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gachon University Gil Medical Center
• Treatments: Gemcitabine

Criteria

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