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Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients

This study has been completed.
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00526110
First received: September 4, 2007
Last updated: September 14, 2016
Last verified: September 2016
Results First Received: June 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Gastrointestinal Diseases
Interventions: Drug: 5-Fluorouracil
Drug: Docetaxel
Drug: Oxaliplatin

  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
Recruitment Period: September 8, 2004 to August 5, 2009. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.

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
Phase I: Dose Escalation Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
Phase II: Docetaxel MTD 50 mg/m^2 Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).

Participant Flow:   Overall Study
    Phase I: Dose Escalation   Phase II: Docetaxel MTD 50 mg/m^2
STARTED   53   45 
COMPLETED   51   4 
NOT COMPLETED   2   41 
Adverse Event                2                9 
Disease Progression                0                19 
Maximal Response                0                6 
Withdrawal by Subject                0                2 
Poor Tolerance                0                5 



  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
Phase I Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
Phase II Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
Total Total of all reporting groups

Baseline Measures
   Phase I   Phase II   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   45   98 
Age 
[Units: Years]
Median (Full Range)
 55 
 (24 to 76) 
 59 
 (34 to 79) 
 57 
 (24 to 79) 
Gender 
[Units: Participants]
     
Female   12   14   26 
Male   41   31   72 
Region of Enrollment 
[Units: Participants]
     
United States   53   45   98 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: 28 days ]

2.  Primary:   Progression Free Survival   [ Time Frame: Assessed from baseline to 30 months ]

3.  Secondary:   Median Overall Survival   [ Time Frame: Up to 30 months ]


  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: Jaffer Ajani, MD/Professor, GI Medical Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
phone: 1-877-632-6789
e-mail: CR_Study_Registration@mdanderson.org


Publications of Results:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00526110     History of Changes
Other Study ID Numbers: 2004-0290
NCI-2010-00750 ( Registry Identifier: NCI CTRP )
Study First Received: September 4, 2007
Results First Received: June 28, 2016
Last Updated: September 14, 2016