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

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.
ClinicalTrials.gov Identifier: NCT00447122
Recruitment Status : Terminated
First Posted : March 14, 2007
Results First Posted : May 19, 2014
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Memorial Hospital of Rhode Island
Information provided by (Responsible Party):
howard safran, Brown University

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
Enrollment 31
Recruitment Details 31 patients were enrolled, 29 were evaluable
Pre-assignment Details  
Arm/Group Title Lapatinib and Gemcitabine
Hide Arm/Group Description lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
Period Title: Overall Study
Started 31
Completed 29 [1]
Not Completed 2
[1]
29 evaluable thus 29 represented in efficacy and safety portion
Arm/Group Title Treatment
Hide Arm/Group Description lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  41.9%
>=65 years
18
  58.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
62  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
13
  41.9%
Male
18
  58.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title Number of Patients Who Survived at 4 Months: Overall Survival
Hide Description [Not Specified]
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib and Gemcitabine
Hide Arm/Group Description:
lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
29
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   1/29 (3.45%)    
Investigations   
pneumocystis sepsis and ARDS   1/29 (3.45%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment
Affected / at Risk (%) # Events
Total   5/29 (17.24%)    
Investigations   
neutropenia   5/29 (17.24%)  5
Indicates events were collected by systematic assessment
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
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: April 27, 2018