Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00084617
First received: June 10, 2004
Last updated: April 15, 2015
Last verified: July 2013
Results First Received: April 15, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Gastroesophageal Junction
Diffuse Adenocarcinoma of the Stomach
Intestinal Adenocarcinoma of the Stomach
Mixed Adenocarcinoma of the Stomach
Recurrent Gastric Cancer
Stage IIIA Gastric Cancer
Stage IIIB Gastric Cancer
Stage IIIC Gastric Cancer
Stage IV Gastric Cancer
Interventions: Drug: oxaliplatin
Drug: irinotecan hydrochloride
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
This was a multi-center single treatment arm study involving four sites. Patients were recruited February 2004 through February 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
Treatment (Oxaliplatin, Irinotecan, Capecitabine) Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Oxaliplatin, Irinotecan, Capecitabine)  
STARTED     39  
COMPLETED     30  
NOT COMPLETED     9  
Withdrawal by Subject                 7  
Lack of Efficacy                 1  
Protocol Violation                 1  



  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
Treatment (Oxaliplatin, Irinotecan, Capecitabine) Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Treatment (Oxaliplatin, Irinotecan, Capecitabine)  
Number of Participants  
[units: participants]
  39  
Age  
[units: years]
Median (Full Range)
  57.8   (31 to 79)  
Gender  
[units: participants]
 
Female     10  
Male     29  
Region of Enrollment  
[units: participants]
 
United States     39  



  Outcome Measures
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1.  Primary:   Response Rates (RR) in Metastatic Gastric/GE Junction Tumors   [ Time Frame: at 12 weeks (after 2 cycles of treatment) ]

2.  Secondary:   Complete Response (CR) and Partial Response (PR) Duration   [ Time Frame: at 40 months from study activation ]

3.  Secondary:   Overall Survival   [ Time Frame: at 40 months from study activation ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Joanna Brell MD
Organization: National Cancer Institute
phone: 240-276-7050
e-mail: brelljm@mail.nih.gov


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00084617     History of Changes
Other Study ID Numbers: NCI-2012-03010, CASE 1203, CDR0000365464, U01CA062502
Study First Received: June 10, 2004
Results First Received: April 15, 2015
Last Updated: April 15, 2015
Health Authority: United States: Food and Drug Administration