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

This study has been terminated.
ClinicalTrials.gov Identifier:
First Posted: March 14, 2007
Last Update Posted: May 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Rhode Island Hospital
The Miriam Hospital
Memorial Hospital of Rhode Island
Information provided by (Responsible Party):
howard safran, Brown University
Results First Submitted: May 21, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
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
COMPLETED   29 [1] 
[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
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
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   13 
>=65 years   18 
[Units: Years]
Mean (Standard Deviation)
 62  (7) 
[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.  

  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

Responsible Party: howard safran, Brown University
ClinicalTrials.gov Identifier: NCT00447122     History of Changes
Other Study ID Numbers: BrUOG-PA-209
First Submitted: March 12, 2007
First Posted: March 14, 2007
Results First Submitted: May 21, 2013
Results First Posted: May 19, 2014
Last Update Posted: May 19, 2014