Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site

This study has been completed.
Sponsor:
Collaborators:
Roche Pharma AG
Sanofi-Synthelabo
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193609
First received: September 12, 2005
Last updated: October 18, 2013
Last verified: October 2013
Results First Received: August 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasms, Unknown Primary
Interventions: Drug: Oxaliplatin
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
Oxaliplatin/Capecitabine All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.

Participant Flow:   Overall Study
    Oxaliplatin/Capecitabine  
STARTED     48  
COMPLETED     44  
NOT COMPLETED     4  
Lack of Efficacy                 2  
Adverse Event                 2  



  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
Intervention All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.

Baseline Measures
    Intervention  
Number of Participants  
[units: participants]
  48  
Age  
[units: years]
Median ( Full Range )
  59  
  ( 25 to 80 )  
Gender  
[units: participants]
 
Female     27  
Male     21  
Region of Enrollment  
[units: participants]
 
United States     48  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival   [ Time Frame: 18 months ]

2.  Secondary:   Overall Survival   [ Time Frame: 18 months ]


  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:  
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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: John Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


Publications of Results:

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193609     History of Changes
Other Study ID Numbers: SCRI UNKPRI 14
Study First Received: September 12, 2005
Results First Received: August 15, 2013
Last Updated: October 18, 2013
Health Authority: United States: Institutional Review Board