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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:
ClinicalTrials.gov Identifier:
NCT00161213
First Posted: September 12, 2005
Last Update Posted: December 27, 2012
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
Results First Submitted: November 21, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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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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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: 4 years ]

2.  Secondary:   Response Rate   [ Time Frame: 5 years ]

3.  Secondary:   1-year Survival Rate   [ Time Frame: 5 years ]

4.  Secondary:   Overall Survival   [ Time Frame: 5 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00161213     History of Changes
Other Study ID Numbers: CDR0000539409
P30CA072720 ( U.S. NIH Grant/Contract )
CINJ-070501 ( Other Identifier: CINJ )
CINJ-5324 ( Other Identifier: CINJ )
CINJ-NJ1205 ( Other Identifier: CINJ )
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: November 21, 2012
Results First Posted: December 27, 2012
Last Update Posted: December 27, 2012