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

NCT01549093 | Unknown Phase 2 DMC

• 1 other identifier: HunanPTH022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  two years

Secondary Outcomes (5)

• Overall survival (OS)

  two years

• Clinical benefit rate (CBR)

  two years

• The level change of CECs,VEGF,TSP-1,VEGFR,P1GF,MVD in blood.

  two years

• adverse reaction

  two years

• Time to progression(TTP)

  two years

Study Arms (3)

Endostar -Continued Pumping into+GC

EXPERIMENTAL

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

Drug: Gemcitabine,Carboplatin,Endostar

Endostar -injecting into +GC

ACTIVE COMPARATOR

Endostar that is injecting into vein with Gemcitabine -Carboplatin

Drug: Gemcitabine(G) Carboplatin(C) Endostar

GC

ACTIVE COMPARATOR

Gemcitabine -Carboplatin

Drug: Gemcitabine(G) Carboplatin(C)

Interventions

Gemcitabine,Carboplatin,Endostar 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 -Continued Pumping into+GC

Gemcitabine(G) Carboplatin(C) Endostar 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

Endostar -injecting into +GC

Gemcitabine(G) Carboplatin(C) 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

GC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

HuNan province tumor hospital

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; endostar protein

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jianhua Chen, master

  Hunan Province Tumor Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhua Chen, master

CONTACT

0086-731-89762221; cjh_1000@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professer

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 8, 2012
• Study Start: August 1, 2011
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

CN (1)