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

Gachon University Gil Medical Center

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Genexol-PM/Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01770795

2011-GIRBA-2351

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

45 participants in 1 patient group

Genexol-PM/Gemcitabine

Experimental group

Treatment:

Drug: Genexol-PM/Gemcitabine