Evaluating Endostatin Plus TC Regimen in Secondary Malignant Neoplasm of Liver Using Contrast Enhancement Ultrasonography
This study is ongoing, but not recruiting participants.
Sponsor:
Sun Yat-sen University
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01347424
First received: April 27, 2011
Last updated: February 12, 2012
Last verified: November 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (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 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: | February 12, 2012 |
| 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 Lung Neoplasms Neoplasm Metastasis Nasopharyngeal Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Digestive System Neoplasms Digestive System Diseases |
Liver Diseases Neoplastic Processes Pathologic Processes Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Carboplatin Paclitaxel Endostatins Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013