Clinical trial NCT01687439: Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer (NSCLC)
Official title: Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective: functional imaging and quantitative imaging detection of the effects of Endostar combined with chemotherapy and radiotherapy on Non-small Cell Lung Cancer (NSCLC).

Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven inoperable stage IIIb-IV NSCLC
* ECOG PS 0-1
* Life expectancy \> 3 months
* Adequate blood functions: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin ≥ 9 g / dL
* Adequate liver function: total bilirubin \<1.5 times the upper limit of normal (ULN); AST and ALT \<2.5 times ULN in patients without liver metastases, \<5 times ULN in patients with liver metastases
* Adequate renal function: serum creatinine ≤ 1.25 times ULN or calculated creatinine clearance ≥ 50 mL / min and urinary protein \<2+. In patients with baseline urinary protein ≥ 2+, 24 hours urine should be collected and 24 hours urine protein ≤ 1g
* International normalized ratio (INR) ≤ 1.5 and prothrombin time(PT) ≤ 1.5 times ULN within 7 days before enrollment
* Written informed consent

Exclusion Criteria:

* Evidence of bleeding diathesis or coagulopathy
* History of hemoptysis, defined as bright red blood more than half a teaspoon 3 months before enrollment
* Previously received chemotherapy and radiotherapy and biological targeted therapy
* Uncontrolled hypertension (systolic blood pressure\> 150 mmHg and/or diastolic blood pressure\> 100 mm Hg)
* Clinically significant (ie, active) cardiovascular diseases, such as cerebrovascular accident (within 6 months before initiating treatment), myocardial infarction (within 6 months before initiating treatment), unstable angina, congestive heart failure (New York Heart Association class ≥Grade II) , serious arrhythmia which needs medication during the study and may affect the study or can not be controlled by drugs
* Unhealed wounds, active peptic ulcer or fracture
* Gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before enrollment
* Women with intact uterus (menopause more than two years excluded) who are unwilling to take effective non-hormonal contraception (IUD, spermicide barrier birth control device or sterilization) during the study. Male who are unwilling to take effective contraceptive measures during the study
* Participated in other clinical trials within 28 days before the initiation of treatment.
* Allergic to any of the study drugs

Primary outcomes:
measure: Tumor blood volume
timeFrame: 3 months
measure: Tumor blood flow
timeFrame: 3 months
measure: Permeability-surface area product
timeFrame: 3 months
measure: 18-FDG PET SUV values
timeFrame: 3 months
Secondary outcomes:
measure: The incidence of adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Guoliang Jiang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Ming Fan, MD
role: PRINCIPAL_INVESTIGATOR
References: