Clinical trial NCT01549093: Endostar Continued Pumping Into Vein Combining With Gemcitabine-Carboplatin to Treat Non-Small Cell Lung Cancer (NSCLC)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer
Endostar
Continued Pumping into
Gemcitabine
Carboplatin
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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),

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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: two years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: two years
measure: Clinical benefit rate (CBR)
timeFrame: two years
measure: The level change of CECs,VEGF,TSP-1,VEGFR,P1GF,MVD in blood.
timeFrame: two years
measure: adverse reaction
timeFrame: two years
measure: Time to progression(TTP)
timeFrame: two years
Other outcomes:
Locations:
city: Changsha
country: China
facility: HuNan province tumor hospital
state: Hunan
Study officials:
affiliation: Hunan Province Tumor Hospital
name: Jianhua Chen, master
role: PRINCIPAL_INVESTIGATOR
References: