A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers
Conditions
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
Progression free Survival
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: pemetrexed /carboplatin
Type: Drug
Overall Status
Recruiting
Summary
PFS
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 70 Years
Gender: Both
Criteria: Inclusion Criteria:

.≥65 years or PS 2

- Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer

- Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD

- Presence of at least one index lesion measurable by CT scan or MRI

- leucocyte ≥ 3.5×109/L

- neutrophil ≥ 1.5×109/L

- platelet ≥ 80×109/L

- Hemoglobin ≥ 9g/L

- ALT and AST ≤ 2.5×ULN ,Tbil≤ 1.5×ULN

- BUN≤ 1.5×ULN

- Signed written informed consent

Exclusion Criteria:

- squamous carcinoma or small cell lung cancer

- Patients were allergic to pemetrexed

- Patients received chemotherapy before

- Uncontrolled acute infection

.Uncontrolled pleural effusion

- Severe symptomatic heart disease

- Severe infection or metabolic disfunction

- Patients with other malignant tumor

- Uncontrolled brain metastases

- Patients have accepted other clinical trials

- Female patients during their pregnant and lactation period, or patients without contraception

- Mental disorientation of disorder

- Glucocorticoids taboo
Location
Cancer hospital Fudan University
Shanghai, Shanghai, China
Status: Recruiting
Contact: Jia lei Wang, Master - 02164175590 - luwangjialei@hotmail.com
Start Date
February 2013
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page