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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)


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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)


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),


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Time Frame:

two years

Safety Issue:

Yes

Principal Investigator

Jianhua Chen, master

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hunan Province Tumor Hospital

Authority:

China: Food and Drug Administration

Study ID:

HunanPTH022

NCT ID:

NCT01549093

Start Date:

August 2011

Completion Date:

October 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small cell lung cancer
  • Endostar
  • Continued Pumping into
  • Gemcitabine
  • Carboplatin
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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