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

NCT01347424 | Unknown Phase 2 DMC

• 1 other identifier: XIANSHENG
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer; Nasopharyngeal Cancer; Liver Metastasis

Keywords

NSCLC; NPC

Outcome Measures

Primary Outcomes (1)

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

  12months

Secondary Outcomes (2)

• 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

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

  12 months

Study Arms (2)

Test group

EXPERIMENTAL

Drug: Paclitaxel , carboplatin, endostatin

control group

ACTIVE COMPARATOR

Drug: Paclitaxel and Carboplatin

Interventions

Paclitaxel , carboplatin, endostatin DRUG

PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w endostatin：7.5 mg/m2 iv 3-4h， d1～15，q3w

Test group

Paclitaxel and Carboplatin DRUG

PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

SunYat-senU

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Nasopharyngeal Neoplasms

Interventions

Paclitaxel; Carboplatin; Endostatins

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• Li Zhang

  Cancer Center of Sun Yat-Sen University (CCSU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: May 4, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 9, 2013

Record last verified: 2010-11

Locations

CN (1)