Evaluating Endostatin Plus TC Regimen in Secondary Malignant Neoplasm of Liver Using Contrast Enhancement Ultrasonography

Non Small Cell Lung Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01347424
• Other study ID #: XIANSHENG
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 27, 2011
• Last updated: December 5, 2013
• Start date: January 2011
• Est. completion date: October 2014

Study information

• Verified date: November 2010
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Contrast enhancement ultrasonography（CEUS）could be used to evaluate the blood flow perfusion liver cancer. In this clinical trial, CEUS was used to evaluated the changes of blood flow perfusion of Secondary Malignant Neoplasm of Liver after treated with endostatin plus paclitaxel and carboplatin regimen.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologic diagnosis of nasopharyngeal carcinoma or NSCLC

• With an evaluable secondary malignant neoplasm of Liver, diameter=2cm

• Without transcatheter arterial chemoembolization (TACE) treatment

• Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.

• Estimated life expectancy of at least 3 months

• Patient compliance and geographic proximity that allow adequate follow-up.

• Adequate organ function including the following: Bone marrow: absolute neutrophil count (ANC) >or= 1.5x10^9/L, platelets >or= 100x10^9/L, hemoglobin >or= 9g/dL. Hepatic: bilirubin <1.5 x ULN, alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 x ULN (alkaline phosphatase, AST, ALT < 5 x ULN is acceptable if liver has tumor involvement). Renal: calculated creatinine clearance > 45 ml/min.

• Men or women of at least 18 years of age.

• Signed informed consent from patient.

Exclusion Criteria:

• Women who are pregnant or in lactation

• Systemic treatment for another cancer within the year prior to study entry

• Known hypersensitivity to any of the study drugs or to drugs with similar chemical structures

• Use of investigational agents within 28 days of the Baseline visit, or participating simultaneously in any other clinical studies

• Severe co-morbidity of any type that may interfere with assessment of the patient for the study

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Liver Metastasis
• Nasopharyngeal Cancer
• Non Small Cell Lung Cancer

Intervention

Drug:
• Paclitaxel , carboplatin, endostatin
PTX:175mg/m2,D1, q3w CBP:AUC5,D1, q3w endostatin:7.5 mg/m2 iv 3-4h, d1~15,q3w
• Paclitaxel and Carboplatin
PTX:175mg/m2,D1, q3w CBP:AUC5,D1, q3w

Locations

Country	Name	City	State
China	SunYat-senU	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of blood flow perfusion in secondary malignant neoplasm of liver		12months	No
Secondary	Comparing the difference of OS(Overall Survival) and ORR(Objective Response Rate) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria in the two different arms.		12 months	No
Secondary	Number of Participants with Adverse Events in the two different arms		12 months	Yes