Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Simcere Pharmaceutical Co., Ltd |
---|---|
Information provided by: | Simcere Pharmaceutical Co., Ltd |
ClinicalTrials.gov Identifier: | NCT00813332 |
The purpose of this study is to compare the efficacy and safety of Endostar (Recombinant Human Endostatin) combined with Docetaxel and single Docetaxel through multi-center, double-blinding, randomized controlled, phase Ⅳ clinical trial for NSCLC cases who have obvious progressive disease or intolerant adverse effects in first-line chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Advanced NSCLC Recurrent NSCLC |
Drug: Endostar(rh recombinant endostatin) plus Docetaxel Drug: Placebo plus Docetaxel |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double Blind , Randomized, Multicenter Study of Second Line Treatment of Endostar(rh Recombined Endostatin)With Single Docetaxel In NSCLC Patients |
Estimated Enrollment: | 300 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Endostar combined with Docetaxel
|
Drug: Endostar(rh recombinant endostatin) plus Docetaxel
7.5mg/m2, IV( in the vein) on day1-14 of each 21-28 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
|
2: Placebo Comparator
Docetaxel combined with placebo
|
Drug: Placebo plus Docetaxel
Placebo plus Docetaxel
|
The combinative therapy of Endostar, Vinorelbine and cisplatin has been shown to increase response rate and survival in patients (pts) with advanced NSCLC and is sFDA-approved for this indication. However, there are limited data on the safety and efficacy of Endostar in combination with other widely used chemotherapy doublets for NSCLC. Clinical data proved that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. In this clinical trial, there will be 160 patients enrollment, giving Docetaxel (75mg/m2,iv, d1, every 3 weeks) plus Endostar(7.5mg/m2/day, iv, d1-d14, every 3 weeks) or Docetaxel with placebo. We'll evaluate the efficacy and safety of the Docetaxel plus Endostar treatment to NSCLC and hope to provide a promising regimen to advanced lung cancer patients.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kai LI, Professor | 0086-22-81351613 | likai5@medmail.com.cn, likqupp@yahoo.com |
Contact: Zhao YAN, Doctor | 0086-22-23948638 | yanzhaotj@126.com |
China | |
Cancer Hospital of Tianjin Medical University | Recruiting |
Tianjin, China, 300060 | |
Contact: Kai LI, Professor 0086-22-81351613 likai5@medmail.com.cn,likqupp@yahoo.com | |
Contact: Zhao YAN, Doctor 0086-22-23948638(Fax23524155) yanzhaotj@126.com | |
Principal Investigator: Kai LI, Professor |
Principal Investigator: | Kai LI, professor | Cancer Hospital of Tianjin Medical University |
Responsible Party: | Cancer Hospital of Tianjin Medical University ( Kai LI/Professor ) |
Study ID Numbers: | simcere002, simcere0802 |
Study First Received: | December 19, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00813332 |
Health Authority: | China: State Food and Drug Administration; United States: Institutional Review Board |
Endostar NSCLC Docetaxel Combined therapy second-line chemotherapy |
Docetaxel Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Endostatins Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Growth Substances |
Therapeutic Uses Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |