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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01347424
First received: April 27, 2011
Last updated: December 5, 2013
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer
Nasopharyngeal Cancer
Liver Metastasis
Drug: Paclitaxel , carboplatin, endostatin
Drug: Paclitaxel and Carboplatin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • The changes of blood flow perfusion in secondary malignant neoplasm of liver [ Time Frame: 12months ] [ Designated as safety issue: No ]

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events in the two different arms [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test group Drug: Paclitaxel , carboplatin, endostatin
PTX:175mg/m2,D1, q3w CBP:AUC5,D1, q3w endostatin:7.5 mg/m2 iv 3-4h, d1~15,q3w
Active Comparator: control group Drug: Paclitaxel and Carboplatin
PTX:175mg/m2,D1, q3w CBP:AUC5,D1, q3w

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347424

Locations
China, Guangdong
SunYat-senU
GuangZhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Li Zhang Cancer Center of Sun Yat-Sen University (CCSU)
  More Information

No publications provided

Responsible Party: Li Zhang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01347424     History of Changes
Other Study ID Numbers: XIANSHENG
Study First Received: April 27, 2011
Last Updated: December 5, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
NSCLC
NPC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Liver Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Carboplatin
Paclitaxel
Endostatins
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014