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

Primary Purpose

Non-Small Cell Lung Cancer

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Carboplatin

Pemetrexed

Endostar

Centrum

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Endostar, Carboplatin, Pemetrexed, NSCLC, Phase I

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endostar plus pemetrexed/carboplatin

Arm Description

21 days as one cycle, for a total of 4-6 cycles

Outcomes

Primary Outcome Measures

Dose Limiting Toxicity

Secondary Outcome Measures

Objective Response Rate

Disease Control Rate

Progression-free Survival

Overall Survival

Full Information

NCT ID

NCT01531790

First Posted

February 7, 2012

Last Updated

January 15, 2013

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01531790

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

Keywords

Endostar, Carboplatin, Pemetrexed, NSCLC, Phase I

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endostar plus pemetrexed/carboplatin

Arm Type

Experimental

Arm Description

21 days as one cycle, for a total of 4-6 cycles

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

d1, AUC 5, i.v.

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Description

d1, 500 mg/m2, i.v.

Intervention Type

Drug

Intervention Name(s)

Endostar

Intervention Description

d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc.

Intervention Type

Drug

Intervention Name(s)

Centrum

Intervention Description

1 tablet/day

Primary Outcome Measure Information:

Title

Dose Limiting Toxicity

Time Frame

up to 21 days

Secondary Outcome Measure Information:

Title

Objective Response Rate

Time Frame

up to 6 cycles

Title

Disease Control Rate

Time Frame

up to 6 cycles

Title

Progression-free Survival

Time Frame

up to 2 years

Title

Overall Survival

Time Frame

up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Zhang, MD

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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