Endostar Continued Pumping Into Vein Combining With Gemcitabine-Carboplatin to Treat Non-Small Cell Lung Cancer (NSCLC)

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Gemcitabine,Carboplatin,Endostar; Drug: Gemcitabine(G) Carboplatin(C) Endostar; Drug: Gemcitabine(G) Carboplatin(C)

• Registration Number: NCT01549093
• Lead Sponsor: Hunan Province Tumor Hospital

Brief Summary

The purpose of this study is to determine whether Endostar with Gemcitabine-Carboplatin are more effective than Gemcitabine-Carboplatin alone in the treatment of Non-Small Cell Lung Cancer (NSCLC),and about Endostar ,Compared with intravenous, Continued vein-pumping maby is a more effective way.

Detailed Description

Endostar have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued vein-pumping Combining with Gemcitabine-Carboplatin (GC)chemotherapy in patients with NSCLC,and seeking for more effective injection.

Methods:

In this randomized, open label, 90 patients are planned to be enrolled at random into 3 arms(1:1:1): Experimental: Endostar -Continued Pumping into+Gemcitabine-Carboplatin(GC),Active Comparator: Endostar -injecting into +Gemcitabine-Carboplatin(GC),Active Comparator: Gemcitabine-Carboplatin(GC),

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-22
• Last Update Posted: 2015-03-24
• Primary Completion: 2016-07
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Histologically or cytologically diagnosed NSCLC;

2. primary treatment,inoperable stage III/IV NSCLC;

3. Age of 18-70years; Gender Not Required;

4. Adequate hematologic, renal, and hepatic function ,Specific index as follows:

   liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l, Hb≥100 g/l;

5. ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;

6. The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);

7. No history of serious drug allergy;

8. Informed consent should be obtained before treatment.

Exclusion Criteria

1. Symptomatic brain metastases with cognitive disorder,bone metastases with complications;
2. Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);
3. Serious complications and investigator consider it is unsuited enrolling;
4. Pregnant or lactating women;
5. Allergic to research drug;
6. participating in other experimental trials and receive the treatment in four weeks;
7. The position that is for observing curative effect have a radiotherapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endostar -Continued Pumping into+GC	Gemcitabine,Carboplatin,Endostar	Endostar that is Continued Pumping into vein Combining With Gemcitabine -Carboplatin
Endostar -injecting into +GC	Gemcitabine(G) Carboplatin(C) Endostar	Endostar that is injecting into vein with Gemcitabine -Carboplatin
GC	Gemcitabine(G) Carboplatin(C)	Gemcitabine -Carboplatin

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	two years

Secondary Outcome Measures

Name	Time	Method
adverse reaction	two years
Overall survival (OS)	two years
Time to progression(TTP)	two years
Clinical benefit rate (CBR)	two years
The level change of CECs,VEGF,TSP-1,VEGFR,P1GF,MVD in blood.	two years

Trial Locations

Locations (1)

HuNan province tumor hospital; 🇨🇳 Changsha, Hunan, China