BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreatic Cancer

This study has been terminated.
Sponsor:
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Memorial Hospital of Rhode Island
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT00447122
First received: March 12, 2007
Last updated: April 17, 2014
Last verified: April 2014
Results First Received: May 21, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Pancreatic Cancer
Intervention: Drug: gemcitabine and Lapatinib

  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
31 patients were enrolled, 29 were evaluable

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 Gemcitabine lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression

Participant Flow:   Overall Study
    Lapatinib and Gemcitabine  
STARTED     31  
COMPLETED     29 [1]
NOT COMPLETED     2  
[1] 29 evaluable thus 29 represented in efficacy and safety portion



  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 lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression

Baseline Measures
    Treatment  
Number of Participants  
[units: participants]
  31  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     13  
>=65 years     18  
Age  
[units: years]
Mean ± Standard Deviation
  62  ± 7  
Gender  
[units: participants]
 
Female     13  
Male     18  
Region of Enrollment  
[units: participants]
 
United States     31  



  Outcome Measures

1.  Primary:   Number of Patients Who Survived at 4 Months: Overall Survival   [ Time Frame: 4 months ]

2.  Secondary:   Toxicity   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Howard Safran, MD
Organization: BrUOG
phone: 4018633000
e-mail: kayla_rosati@brown.edu


No publications provided


Responsible Party: howard safran, Brown University
ClinicalTrials.gov Identifier: NCT00447122     History of Changes
Other Study ID Numbers: BrUOG-PA-209
Study First Received: March 12, 2007
Results First Received: May 21, 2013
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration