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

Purpose

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.

Condition	Intervention	Phase
Non-small Cell Lung Cancer	Drug: Gemcitabine,Carboplatin,Endostar Drug: Gemcitabine(G) Carboplatin(C) Endostar Drug: Gemcitabine(G) Carboplatin(C)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open Label, Controlled Study About Endostar Continued Pumping or Injecting Into Vein Combining With Gemcitabine-Carboplatin Versus Gemcitabine-Carboplatin Alone to Treat Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Hunan Province Tumor Hospital:

Primary Outcome Measures:

Progression free survival (PFS) [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall survival (OS) [ Time Frame: two years ] [ Designated as safety issue: Yes ]
Clinical benefit rate (CBR) [ Time Frame: two years ] [ Designated as safety issue: Yes ]
The level change of CECs,VEGF,TSP-1,VEGFR,P1GF,MVD in blood. [ Time Frame: two years ] [ Designated as safety issue: No ]
adverse reaction [ Time Frame: two years ] [ Designated as safety issue: No ]
Time to progression(TTP) [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	August 2011
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Endostar -Continued Pumping into+GC Endostar that is Continued Pumping into vein Combining With Gemcitabine -Carboplatin	Drug: 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.
Active Comparator: Endostar -injecting into +GC Endostar that is injecting into vein with Gemcitabine -Carboplatin	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
Active Comparator: GC Gemcitabine -Carboplatin	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

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),

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically diagnosed NSCLC;
primary treatment,inoperable stage III/IV NSCLC;
Age of 18-70years; Gender Not Required;
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;
ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;
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);
No history of serious drug allergy;
Informed consent should be obtained before treatment.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549093

Contacts

Contact: Jianhua Chen, master

0086-731-89762221

cjh_1000@163.com

Locations

China, Hunan
HuNan province tumor hospital	Recruiting
Changsha, Hunan, China, 410000
Contact: Jianhua Chen, master 0086-731-89762221 cjh_1000@163.com
Principal Investigator: Jianhua Chen, master

Sponsors and Collaborators

Hunan Province Tumor Hospital

Investigators

Principal Investigator:

Jianhua Chen, master

Hunan Province Tumor Hospital

More Information

No publications provided

Responsible Party:	Jianhua Chen, professer, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier:	NCT01549093 History of Changes
Other Study ID Numbers:	HunanPTH022
Study First Received:	February 27, 2012
Last Updated:	March 6, 2012
Health Authority:	China: Food and Drug Administration

Keywords provided by Hunan Province Tumor Hospital:

Non-small cell lung cancer
Endostar
Continued Pumping into
Gemcitabine
Carboplatin

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on June 18, 2013