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

Phase 1

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Carboplatin; Drug: Pemetrexed; Drug: Endostar; Drug: Centrum

• Registration Number: NCT01531790
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-13
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endostar plus pemetrexed/carboplatin	Centrum	21 days as one cycle, for a total of 4-6 cycles
Endostar plus pemetrexed/carboplatin	Carboplatin	21 days as one cycle, for a total of 4-6 cycles
Endostar plus pemetrexed/carboplatin	Pemetrexed	21 days as one cycle, for a total of 4-6 cycles
Endostar plus pemetrexed/carboplatin	Endostar	21 days as one cycle, for a total of 4-6 cycles

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity	up to 21 days

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	up to 6 cycles
Disease Control Rate	up to 6 cycles
Progression-free Survival	up to 2 years
Overall Survival	up to 2 years

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China