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Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer

This study has been terminated.
(slow enrollment)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Ruth He, Georgetown University
ClinicalTrials.gov Identifier:
NCT00881621
First received: April 13, 2009
Last updated: January 17, 2017
Last verified: January 2017
Results First Received: March 15, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreas Cancer
Intervention: Drug: Lapatinib and 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
Due to change of practice, it is difficult to complete the enrollment for the study

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
Lapatinib and Capecitabine

Treatment

Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles


Participant Flow:   Overall Study
    Lapatinib and Capecitabine
STARTED   51 
COMPLETED   17 
NOT COMPLETED   34 
Physician Decision                34 



  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
Lapatinib and Capecitabine

Treatment

Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles


Baseline Measures
   Lapatinib and Capecitabine 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      13  76.5% 
>=65 years      4  23.5% 
Gender 
[Units: Participants]
Count of Participants
 
Female      4  23.5% 
Male      13  76.5% 
ECOG [1] 
[Units: Participants]
 
ECOG PS 0   3 
ECOG PS 1   12 
ECOG PS2   2 
[1]

ECOG PERFORMANCE STATUS* Grade 0: Fully active, able to carry on all pre-disease performance without restriction

1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5: Dead



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: 24 months ]

2.  Secondary:   Clinical Benefit Response   [ Time Frame: 3 months ]

3.  Secondary:   Progression Free Survival   [ Time Frame: 24 months ]

4.  Secondary:   Adverse Events   [ Time Frame: 2 years ]


  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: Dr. Aiwu Ruth He
Organization: Georgetown University
phone: 202-444-8642
e-mail: arh29@georgetown.edu



Responsible Party: Ruth He, Georgetown University
ClinicalTrials.gov Identifier: NCT00881621     History of Changes
Other Study ID Numbers: 011438
IND #103,981 ( Other Identifier: FDA )
2008-437 ( Other Identifier: IRB )
Study First Received: April 13, 2009
Results First Received: March 15, 2015
Last Updated: January 17, 2017