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A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201825
First received: September 12, 2005
Last updated: October 1, 2014
Last verified: October 2014
Results First Received: September 25, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lung Cancer
Non-Small-Cell Lung Carcinoma
Interventions: Drug: Capecitabine
Drug: Docetaxel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled and received treatment between December 2004 and November 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Docetaxel and Capecitabine

Capecitabine: 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.

Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks.


Participant Flow:   Overall Study
    Docetaxel and Capecitabine  
STARTED     29  
COMPLETED     29  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible patients had histologically confirmed advanced NSCLC and had not received prior chemotherapy.

Reporting Groups
  Description
Docetaxel and Capecitabine

Capecitabine: 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.

Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks.


Baseline Measures
    Docetaxel and Capecitabine  
Number of Participants  
[units: participants]
  29  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 39 to 76 )  
Gender  
[units: patients]
 
Female     7  
Male     22  
Race (NIH/OMB)  
[units: patients]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     25  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: patients]
 
United States     29  
Histology  
[units: patients]
 
Adenocarcinoma     13  
Squamous cell carcinoma     6  
Large cell Carcinoma     2  
NSCLC not specified     8  
ECOG (Eastern Cooperative Oncology Group)  
[units: patients]
 
Performance status 0 (Fully active)     8  
Performance status 1 (Restricted activity)     21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Determine Objective Response Rate   [ Time Frame: Every 35 days ]

2.  Secondary:   Time to Tumor Progression   [ Time Frame: Every 35 days ]

3.  Secondary:   One Year Survival   [ Time Frame: one year ]

4.  Secondary:   Pharmacokinetics   [ Time Frame: Cycle 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Tanios Bekaii-Saab, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-6529
e-mail: Tanios.Saab@osumc.edu


Publications of Results:

Responsible Party: Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201825     History of Changes
Other Study ID Numbers: OSU-0356, NCI-2011-03593
Study First Received: September 12, 2005
Results First Received: September 25, 2014
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration