NCT00201825|CompletedPhase 2ResultsDMC
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Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trials Reporting Program)
interventional
29
1 country
1
Study Start
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
April 2013
Actual (reported)This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 12, 2005
Actual (reported)September 20, 2005
Actual (reported)December 2012
Actual (reported)April 2013
Actual (reported)October 6, 2014
Actual (reported)Determine Objective Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Every 35 days
Time to Tumor Progression
Every 35 days
One Year Survival
one year
Pharmacokinetics
Cycle 2
1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
36 mg/m2 IV weekly for 3 weeks every 4 weeks.
Ohio State University
Columbus, Ohio, 43210, United States
Bertino EM, Bekaii-Saab T, Fernandez S, Diasio RB, Karim NA, Otterson GA, Villalona-Calero MA. A phase II study of modulated-capecitabine and docetaxel in chemonaive patients with advanced non-small cell lung cancer (NSCLC). Lung Cancer. 2013 Jan;79(1):27-32. doi: 10.1016/j.lungcan.2012.09.013. Epub 2012 Oct 16.
Tony Bekaii-Saab
Ohio State University
29 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2012
Actual (reported)Study Completion
April 2013
Actual (reported)Last Updated
October 6, 2014
Results First Posted
October 6, 2014
Record last verified: 2014-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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