Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
(Roche has withdrawn support)
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Roche Pharma AG
Information provided by (Responsible Party):
Nathan Bahary, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177255
First received: September 12, 2005
Last updated: January 10, 2016
Last verified: January 2016
Results First Received: January 10, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cancer
Interventions: Drug: Docetaxel
Drug: Capecitabine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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 + 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
  Hide Baseline Characteristics

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  
Number of Participants  
[units: participants]
  39  
Age  
[units: years]
Median (Full Range)
  61  
  (21 to 84)  
Gender  
[units: participants]
 
Female     7  
Male     32  



  Outcome Measures
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
  Hide More Information

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
Study First Received: September 12, 2005
Results First Received: January 10, 2016
Last Updated: January 10, 2016
Health Authority: United States: Food and Drug Administration