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Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00161213
First received: September 8, 2005
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
Results First Received: November 21, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Drug: gemcitabine hydrochloride
Drug: imatinib mesylate

  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
The recruitment period spanned from October 2005 through July 2009. The trial was opened at a single regional cancer center and then expanded to other centers to reach accrual goals within the target period. These included hospitals in the CINJ Oncology Group and Northwestern University's Robert H. Lurie Comprehensive Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Gemcitabine and Imatinib

imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.

gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days.

Participant Flow:   Overall Study
    Gemcitabine and Imatinib  
STARTED     44  
COMPLETED     42  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Evaluable for toxicity but not response                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Gemcitabine and Imatinib

imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.

gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days.

Baseline Measures
    Gemcitabine and Imatinib  
Number of Participants  
[units: participants]
 		  44  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     24  
>=65 years     20  
Age  
[units: years]
Mean ± Standard Deviation 		  63  ± 10  
Gender  
[units: participants]
 		 
Female     22  
Male     22  
Region of Enrollment  
[units: participants]
 		 
United States     44  



  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: 4 years ]
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2.  Secondary:   Response Rate   [ Time Frame: 5 years ]
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3.  Secondary:   1-year Survival Rate   [ Time Frame: 5 years ]
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4.  Secondary:   Overall Survival   [ Time Frame: 5 years ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Dr. Susan Goodin (Deputy Director, Associate Director for Clinical Science)
Organization: UMDNJ
phone: 732-235-6783
e-mail: goodin@umdnj.edu


Publications of Results:


Responsible Party: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00161213     History of Changes
Other Study ID Numbers: CDR0000539409, P30CA072720, CINJ-070501, CINJ-5324, CINJ-NJ1205
Study First Received: September 8, 2005
Results First Received: November 21, 2012
Last Updated: November 21, 2012
Health Authority: United States: Institutional Review Board