Lapatinib Ditosylate in Treating Patients With Unresectable Liver or Biliary Tract Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00107536
First received: April 5, 2005
Last updated: April 8, 2015
Last verified: March 2015
Results First Received: October 24, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Recurrent Extrahepatic Bile Duct Cancer
Recurrent Gallbladder Cancer
Unresectable Extrahepatic Bile Duct Cancer
Unresectable Gallbladder Cancer
Interventions: Drug: lapatinib ditosylate
Other: laboratory biomarker analysis

  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
Patients were enrolled between the dates of March 3, 2006-May 14, 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
Lapatinib

Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

lapatinib ditosylate

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Lapatinib  
STARTED     26  
COMPLETED     26  
NOT COMPLETED     0  



  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
Arm I

Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

lapatinib ditosylate

laboratory biomarker analysis: Correlative studies


Baseline Measures
    Arm I  
Number of Participants  
[units: participants]
  26  
Age  
[units: years]
Median (Full Range)
  58   (29 to 81)  
Gender  
[units: participants]
 
Female     8  
Male     18  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     25  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     20  
More than one race     0  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 
United States     26  
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]
[units: participants]
 
Performance status 0     12  
Performance status 1     14  
Sites of metastasis  
[units: participants]
 
Lymph nodes     8  
Lungs     8  
Spine     1  
Bone     1  
Adrenal gland     1  
Peritoneal mets     1  
Hepatic mets     1  
Chest wall     1  
Not available     4  
Prior treatments  
[units: participants]
 
X-ray treatment     3  
Chemo-embolization     2  
Surgery     16  
Chemotherapy     3  
Unknown     2  
[1]

ECOG Performance status 0 is defined as fully active, able to carry on all pre-disease performance without restriction

ECOG Performance status 1 is defined as 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




  Outcome Measures
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1.  Primary:   Proportion of Patients Demonstrating Objective Response (PR+CR) as Defined by RECIST   [ Time Frame: Up to 3 years ]

2.  Secondary:   Progression-free Survival   [ Time Frame: up to 6 months ]

3.  Secondary:   Toxicity Profile Assessed Using NCI CTCAE Version 3.0   [ Time Frame: Up to 3 years ]

4.  Secondary:   Median Overall Survival   [ Time Frame: Up to 3 years ]

5.  Secondary:   Overall Survival   [ Time Frame: up to 12.6 months ]

6.  Secondary:   Target-EGFR/EGFR-P Protein Expression   [ Time Frame: Up to 3 years ]

7.  Secondary:   Expression Profile and Mutations of Genes Critical for EGFR and ERBB2 Signaling Pathways   [ Time Frame: Up to 3 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: Tanio Bekaii-Saab, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-9863
e-mail: Tanios.Bekaii-Saab@osumc.edu


Publications of Results:
Other Publications:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00107536     History of Changes
Other Study ID Numbers: NCI-2012-01464, OSU 0447, N01CM62207, N01CM62201, CDR0000420830
Study First Received: April 5, 2005
Results First Received: October 24, 2014
Last Updated: April 8, 2015
Health Authority: United States: Food and Drug Administration