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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced NSCLC Patients

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Pemetrexed
* Drug: Endostar
* Drug: Centrum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endostar plus pemetrexed/carboplatin<br>21 days as one cycle, for a total of 4-6 cycles | Drug: Carboplatin<br>* d1, AUC 5, i.v.<br>Drug: Pemetrexed<br>* d1, 500 mg/m2, i.v.<br>Drug: Endostar<br>* d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc.<br>Drug: Centrum<br>* 1 tablet/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Limiting Toxicity |  | up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endostar, Carboplatin, Pemetrexed, NSCLC, Phase I