A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (NSCLC) patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Carboplatin; Endostar protein; Pemetrexed

Criteria

Inclusion Criteria:

• Histological or cytological diagnosis of inoperable stage IIIB/IV non-squamous NSCLC

• At least one measurable lesion (RECIST criteria)

• Life expectancy > 3 months

• ECOG performance status 0-2

• Adequate hematologic function: WBC ≥ 3.0×109 /L，ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L

• Adequate renal, hepatic and coagulation function

• Written informed consent

Exclusion Criteria:

• With uncontrollable malignant pleural effusion or ascites

• Thoracic or abdominal surgery within 28 days prior to study entry

• History of cerebral stroke or TIA within 6 months prior to study entry

• With uncontrollable hypertension, hypertensive emergency or hypertensive encephalopathy

• Arrhythmia in need of antiarrhythmic treatment, history of angina pectoris, myocardial infarction, myocardial ischemia or congestive heart failure (> NYHA class II)

• With serious infection (> NCI CTC grade 2)

• Gastrointestinal perforation, fistula formation, and/or intra-abdominal abscess within 6 months prior to study entry

• Symptomatic brain metastases

• Patient who has epilepsy

• History of HIV infection or chronic hepatitis B or C

• Allergic to any of the study drugs

• Pregnant or lactating women