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

Simcere

Status and phase

Completed

Phase 1

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Centrum

Drug: Endostar

Drug: Pemetrexed

Drug: Carboplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01531790

SIM-93

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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