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Paclitaxel Plus Carboplatin With Endostar in Patients of Advanced Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd, January 2009
Sponsored by: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Information provided by: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00708812
  Purpose

In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between July 5 2007 and July 30 2008 are planned to enroll in randomized into 2 groups from 10 centers: the experimental group and control group (1:1). The code-breaking time estimate is about June 2009. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital. Main eligibility criteria were histologically or cytologically proven stage III or IV NSCLC, with an age of 18-75 years. All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients with the curative effect reaches above SD or SD were randomized to receive endostar® plus TC or TC alone for 3 cycles. Each 21-day cycle consisted of endostar® 7.5mg/m2 on days 8 to days 21, carboplatin AUC 5 on day 1, and paclitaxel 175 mg/m on day 1. Primary endpoint: time to progression (TTP). Secondary endpoint:Progress Free Survival (PFS).1 year survival rate. objective response(OR), clinical benefit rate(CBR), median survival time (MST), quality of life (QOL) and remission rate of clinical symptom.


Condition Intervention Phase
Advanced Non-Small Cell Lung Cancer
Drug: Endostar(Recombinant Human Endostatin Injection)
Phase IV

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Paclitaxel Endostatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Paclitaxel Plus Carboplatin (TC) Versus TC Plus Endostar in Patients With Advanced Non-Small Cell Lung Cancer(NSCLC): Randomized, Double-Blind, Placebo-Controlled, Multicentre Study

Further study details as provided by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Time to Progression. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progress Free Survival,1 year survival,objective response,clinical benefit rate,median survival time,quality of life and remission rate of clinical symptom [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: July 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
paclitaxel-carboplatin
Drug: Endostar(Recombinant Human Endostatin Injection)
Each 21-day cycle consist of endostar 7.5mg/m2 on days 8 to days 21.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically or cytologically proven stage III or IV NSCLC
  • age of 18-75 years
  • All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients with the curative effect reaches above SD or SD. without main organ functional disturbance
  • ECOG PS 0-2 with definite focus of infection(RECIST)

Exclusion Criteria:

  • brain metastases with Symptomatic
  • Severity Organ functional defect
  • backward heart failure
  • high risk arrhythmia with severity complication
  • pregnant woman and lactation female
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708812

Contacts
Contact: Han baohui, Ph.D 86-021-6282-1990 hbaohui@yahoo.com

Locations
China
Shanghai Chest Hospital Recruiting
Shanghai, China, 200039
Contact: Han baohui, Ph.D     86-021-6282-1990     hbaohui@yahoo.com    
Principal Investigator: Han baohui, Ph.D            
Sponsors and Collaborators
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
  More Information

Responsible Party: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd ( Jinsheng Ren )
Study ID Numbers: XYL014
Study First Received: June 21, 2008
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00708812  
Health Authority: China: Ethics Committee

Keywords provided by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd:
Non-small Cell Lung Cancer
Endostar
Paclitaxel
Carboplatin

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Endostatins
Carboplatin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 14, 2009