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A Study of Docetaxel in Combination With Capecitabine in Stomach and Esophagus Cancers

This study has been terminated.
(Roche has withdrawn support)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00177255
First Posted: September 15, 2005
Last Update Posted: February 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Aventis Pharmaceuticals
Roche Pharma AG
Information provided by (Responsible Party):
Nathan Bahary, MD, University of Pittsburgh
Results First Submitted: January 10, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cancer
Interventions: Drug: Docetaxel
Drug: Capecitabine

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Docetaxel + Capecitabine

Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.

Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).

Each cycle will consist of 21 days. Cycle 2 will begin on day 22.

Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.

Cycle 2 will begin on day 22.

Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).

Each cycle will consist of 21 days.

Cycle 2 will begin on day 22.


Participant Flow:   Overall Study
    Docetaxel + Capecitabine
STARTED   39 
COMPLETED   39 
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.
No text entered.

Reporting Groups
  Description
Docetaxel + Capecitabine

Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.

Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).

Each cycle will consist of 21 days. Cycle 2 will begin on day 22.

Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.

Cycle 2 will begin on day 22.

Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).

Each cycle will consist of 21 days.

Cycle 2 will begin on day 22.


Baseline Measures
   Docetaxel + Capecitabine 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Years]
Median (Full Range)
 61 
 (21 to 84) 
Gender 
[Units: Participants]
 
Female   7 
Male   32 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: 2 years ]

2.  Secondary:   Overall Response Rate   [ Time Frame: Every 2 cycles (6 weeks) ]


  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
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  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: Nathan Bahary, MD
Organization: University of Pittsburgh
phone: 412-864-7764
e-mail: baharyn@upmc.edu



Responsible Party: Nathan Bahary, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177255     History of Changes
Other Study ID Numbers: 04-026
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: January 10, 2016
Results First Posted: February 8, 2016
Last Update Posted: February 8, 2016