Second-line Therapy Study of Combined Chemotherapy and Endostar to Patients With Non-Small Cell Lung Cancer(NSCLC)
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|ClinicalTrials.gov Identifier: NCT00813332|
Recruitment Status : Unknown
Verified December 2009 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was: Recruiting
First Posted : December 23, 2008
Last Update Posted : January 25, 2010
|Condition or disease||Intervention/treatment||Phase|
|Advanced NSCLC Recurrent NSCLC||Drug: Endostar(rh recombinant endostatin) plus Docetaxel Drug: Placebo plus Docetaxel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Double Blind , Randomized, Multicenter Study of Second Line Treatment of Endostar（rh Recombined Endostatin）With Single Docetaxel In NSCLC Patients|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||October 2009|
|Estimated Study Completion Date :||October 2010|
Endostar combined with Docetaxel for Advanced NSCLC: All eligible patients will receive Endostar in combination with Docetaxel chemotherapy for 2 cycles (21 days for each cycle) and cases of good response(CR+PR+SD) will continue treatment for 2 cycles. Endostar treatment will continue after completion of first 4 cycles until disease progression.
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.
Other Name: Experimental group
Placebo Comparator: 2
Docetaxel combined with placebo for Advanced NSCLC: All eligible patients will receive placebo in combination with Docetaxel chemotherapy for 2 cycles (21 days for each cycle) and cases of good response(CR+PR+SD) will continue treatment for 2 cycles. Placebo will continue after completion of first 4 cycles until disease progression.
Drug: Placebo plus Docetaxel
Placebo plus Docetaxel
Other Name: control group
- Progression-free survival time,survival rate for 1 year [ Time Frame: two years (2010.10) ]
- Tumor response rate, disease controlled rate and adverse effects. [ Time Frame: 1 year (2009.10) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813332
|Contact: Kai LI, Professorfirstname.lastname@example.org, email@example.com|
|Contact: Zhao YAN, Doctorfirstname.lastname@example.org|
|Cancer Hospital of Tianjin Medical University||Recruiting|
|Tianjin, China, 300060|
|Contact: Kai LI, Professor 0086-22-81351613 email@example.com,firstname.lastname@example.org|
|Contact: Zhao YAN, Doctor 0086-22-23948638(Fax23524155) email@example.com|
|Principal Investigator: Kai LI, Professor|
|Principal Investigator:||Kai LI, professor||Cancer Hospital of Tianjin Medical University|