Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC

Stage III Non-small-Cell Lung Cancer Clinical Trial

Official title:

Multicenter Phase I/II Clinical Trial of Recombinant Human Endostatin Continued Pumping Into Vein Combining With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733589
• Other study ID #: [2012]-10-24
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 2, 2012
• Last updated: July 11, 2017
• Start date: November 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2017
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the local control of tumors, especially the squamous cell carcinomas. Preclinical models have shown that Endostar may transiently "normalize" the tumor vasculature to make it more efficient for oxygen delivery, thereby providing a window of opportunity for enhanced sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen in patients with unresectable stage III NSCLC.

Description:

Primary

Evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).

Secondary

Measure changes in VEGF and other angiogenic cytokines and antiangiogenic factors in plasma samples from these patients.

Evaluate the application of CT perfusion imaging to determine changes in tumor vascular mophology and function during treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• untreated histologic or cytologic of NSCLC verified

• inoperable stage IIIA or IIIB NSCLC

• measurable disease by RECIST

• 18~70 years of age

• an ECOG PS of 0 to 1

• absolute neutrophil count (ANC) of =1500/µL, hemoglobin =10gm/dL, platelet =100,000/µL

• serum creatinine =1.25 times of upper limit of normal (ULN), calculated creatinine clearance (CrCl) of =60ml/min

• bilirubin 1.5×ULN, AST and ALT less than 2.5×ULN, alkaline phosphatase less than 5×ULN

• forced vital capacity in 1 second (FEV1) higher than 0.8 L

• CB6 is normal

• Written informed consent

Exclusion Criteria:

• a history of other malignant diseases

• any contraindications for chemoradiotherapy

• distant metastasis

• malignant pleural and/or pericardial effusion

• pregnant or nursing

• preexisting bleeding diatheses or coagulopathy

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage III Non-small-Cell Lung Cancer

Intervention

Drug:
• Recombinant human endostatin
Recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7,combined with concurrent chemo-radiotherapy.
• Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles

• cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles

Other:
• laboratory biomarker analysis

• CT perfusion imaging

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (9)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital	Beijing Cancer Hospital, Chinese Academy of Medical Sciences, Fudan University, Fujian Cancer Hospital, Jiangsu Cancer Institute & Hospital, Shandong Cancer Hospital and Institute, The First People's Hospital of Lianyungang, Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	from beginning treatment to progressive disease or the last follow-up	2-year
Secondary	Response rate	complete response(CR); partial response(PR); stable disease(SD); progressive disease(PD)	1 month
Secondary	overall survival	from date of beginning treatment until date of death	5 years
Secondary	treatment related toxicities	radiation-induced esophagitis; radiation-induced pneumonia	3 months