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

Primary Purpose

Non Small Cell Lung Cancer, Nasopharyngeal Cancer, Liver Metastasis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Paclitaxel , carboplatin, endostatin
Paclitaxel and Carboplatin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC, NPC

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SunYat-senU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test group

control group

Arm Description

Outcomes

Primary Outcome Measures

The changes of blood flow perfusion in secondary malignant neoplasm of liver

Secondary Outcome Measures

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.
Number of Participants with Adverse Events in the two different arms

Full Information

First Posted
April 27, 2011
Last Updated
December 5, 2013
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01347424
Brief Title
Evaluating Endostatin Plus TC Regimen in Secondary Malignant Neoplasm of Liver Using Contrast Enhancement Ultrasonography
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Nasopharyngeal Cancer, Liver Metastasis
Keywords
NSCLC, NPC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Paclitaxel , carboplatin, endostatin
Intervention Description
PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w endostatin：7.5 mg/m2 iv 3-4h， d1～15，q3w
Intervention Type
Drug
Intervention Name(s)
Paclitaxel and Carboplatin
Intervention Description
PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w
Primary Outcome Measure Information:
Title
The changes of blood flow perfusion in secondary malignant neoplasm of liver
Time Frame
12months
Secondary Outcome Measure Information:
Title
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.
Time Frame
12 months
Title
Number of Participants with Adverse Events in the two different arms
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhang
Organizational Affiliation
Cancer Center of Sun Yat-Sen University (CCSU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
SunYat-senU
City
GuangZhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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