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

NCT ID: NCT01549093

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2016-10-31

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),

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endostar -Continued Pumping into+GC

Endostar that is Continued Pumping into vein Combining With Gemcitabine -Carboplatin

Group Type: EXPERIMENTAL

Gemcitabine,Carboplatin,Endostar

Intervention Type: DRUG

Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 48hours and the dosage is 7.5mg/m2\*2 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-6cycles.

Endostar -injecting into +GC

Endostar that is injecting into vein with Gemcitabine -Carboplatin

Group Type: ACTIVE_COMPARATOR

Gemcitabine(G) Carboplatin(C) Endostar

Intervention Type: DRUG

Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-6cycles

GC

Gemcitabine -Carboplatin

Group Type: ACTIVE_COMPARATOR

Gemcitabine(G) Carboplatin(C)

Intervention Type: DRUG

Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; 21 days is one cycle.Continued using 2-6cycles

Interventions

Gemcitabine,Carboplatin,Endostar

Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 48hours and the dosage is 7.5mg/m2\*2 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-6cycles.

Intervention Type: DRUG

Gemcitabine(G) Carboplatin(C) Endostar

Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-6cycles

Intervention Type: DRUG

Gemcitabine(G) Carboplatin(C)

Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; 21 days is one cycle.Continued using 2-6cycles

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Province Tumor Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jianhua Chen

professer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianhua Chen, master

Role: PRINCIPAL_INVESTIGATOR

Hunan Province Tumor Hospital

Locations

HuNan province tumor hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianhua Chen, master

Role: CONTACT

cjh_1000@163.com

0086-731-89762221

Facility Contacts

Jianhua Chen, master

Role: primary

cjh_1000@163.com

0086-731-89762221

Other Identifiers

HunanPTH022

Identifier Type: -

Identifier Source: org_study_id