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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531790
• Other study ID #: SIM-93
• Status: Completed
• Phase: Phase 1
• First received: February 7, 2012
• Last updated: January 15, 2013
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Carboplatin
d1, AUC 5, i.v.
• Pemetrexed
d1, 500 mg/m2, i.v.
• Endostar
d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc.
• Centrum
1 tablet/day

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity		up to 21 days	Yes
Secondary	Objective Response Rate		up to 6 cycles	No
Secondary	Disease Control Rate		up to 6 cycles	No
Secondary	Progression-free Survival		up to 2 years	No
Secondary	Overall Survival		up to 2 years	No