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Trial record 11 of 858 for:    Pancreatic Cancer AND Progression-free survival

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

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ClinicalTrials.gov Identifier: NCT00161213
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : December 27, 2012
Last Update Posted : December 27, 2012
Sponsor:
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 )

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
Enrollment 44
Recruitment Details 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  
Arm/Group Title Gemcitabine and Imatinib
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 44
Completed 42
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Evaluable for toxicity but not response             1
Arm/Group Title Gemcitabine and Imatinib
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
  54.5%
>=65 years
20
  45.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
63  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
22
  50.0%
Male
22
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants
44
1.Primary Outcome
Title Progression-free Survival
Hide Description Progression-free survival in months.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.
Arm/Group Title Gemcitabine and Imatinib
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 42
Median (95% Confidence Interval)
Unit of Measure: months
3.9
(2.06 to 5.14)
2.Secondary Outcome
Title Response Rate
Hide Description Response rate as defined by a best response of "Stable Disease or better."
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response. Seven subjects were not assessed for response as they discontinued therapy treatment before response was assessed.
Arm/Group Title Gemcitabine and Imatinib
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of total evaluable subjects
48.6
(33.0 to 64.4)
3.Secondary Outcome
Title 1-year Survival Rate
Hide Description Percentage of subjects who survive up to 1 year
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.
Arm/Group Title Gemcitabine and Imatinib
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of total evaluable subjects
25.6
(13.8 to 39.1)
4.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.
Arm/Group Title Gemcitabine and Imatinib
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 42
Median (95% Confidence Interval)
Unit of Measure: months
6.23
(5.15 to 8.46)
Time Frame 5 years
Adverse Event Reporting Description All patients who received one dose of protocol therapy were evaluated for toxicity.
 
Arm/Group Title Gemcitabine and Imatinib
Hide Arm/Group Description

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.

All-Cause Mortality
Gemcitabine and Imatinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine and Imatinib
Affected / at Risk (%) # Events
Total   6/43 (13.95%)    
Blood and lymphatic system disorders   
Neutrophils/granulocytes (ANC/AGC)  1  1/43 (2.33%)  1
Gastrointestinal disorders   
Pain - Abdomen not otherwise specified  1  2/43 (4.65%)  2
Nausea  1  2/43 (4.65%)  2
Stricture/stenosis (including anastomotic), GI - Biliary tree  1  1/43 (2.33%)  1
Dehydration  1  1/43 (2.33%)  1
General disorders   
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  2/43 (4.65%)  3
Hepatobiliary disorders   
Liver dysfunction/failure (clinical)  1  1/43 (2.33%)  1
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils - Biliary tree  1  1/43 (2.33%)  1
Metabolism and nutrition disorders   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  1/43 (2.33%)  1
Bilirubin (hyperbilirubinemia)  1  1/43 (2.33%)  1
Psychiatric disorders   
Mood alteration - Depression - pre-existing condition  1  1/43 (2.33%)  1
Psychosis (hallucinations/delusions)  1  1/43 (2.33%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  1/43 (2.33%)  1
Vascular disorders   
Thrombosis/thrombus/embolism - pulmonary embolus  1  1/43 (2.33%)  1
Hemorrhage, GI - Lower GI NOS  1  1/43 (2.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gemcitabine and Imatinib
Affected / at Risk (%) # Events
Total   39/43 (90.70%)    
Blood and lymphatic system disorders   
Neutrophils/granulocytes (ANC/AGC)  1  25/43 (58.14%)  66
Leukocytes (total WBC)  1  20/43 (46.51%)  42
Hemoglobin  1  17/43 (39.53%)  31
Platelets  1  12/43 (27.91%)  30
Blood/Bone Marrow - Other (Specify, __)  1  3/43 (6.98%)  3
Edema: limb  1  8/43 (18.60%)  9
Gastrointestinal disorders   
Nausea  1  22/43 (51.16%)  97
Constipation  1  12/43 (27.91%)  15
Anorexia  1  11/43 (25.58%)  11
Diarrhea  1  9/43 (20.93%)  9
Vomiting  1  9/43 (20.93%)  9
Dehydration  1  4/43 (9.30%)  4
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  19/43 (44.19%)  27
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  9/43 (20.93%)  11
Weight loss  1  5/43 (11.63%)  5
Pain - Abdomen NOS  1  11/43 (25.58%)  18
Pain - Back  1  3/43 (6.98%)  3
Pain - Other (Specify, __)  1  3/43 (6.98%)  4
Metabolism and nutrition disorders   
Alkaline phosphatase  1  6/43 (13.95%)  7
Albumin, serum-low (hypoalbuminemia)  1  4/43 (9.30%)  4
ALT, SGPT (serum glutamic pyruvic transaminase)  1  4/43 (9.30%)  4
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  3/43 (6.98%)  3
Glucose, serum-high (hyperglycemia)  1  3/43 (6.98%)  3
Nervous system disorders   
Memory impairment  1  4/43 (9.30%)  4
Confusion  1  3/43 (6.98%)  3
Psychiatric disorders   
Mood alteration - Depression  1  3/43 (6.98%)  3
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  4/43 (9.30%)  4
Skin and subcutaneous tissue disorders   
Rash/desquamation  1  6/43 (13.95%)  6
Vascular disorders   
Thrombosis/thrombus/embolism  1  5/43 (11.63%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Susan Goodin (Deputy Director, Associate Director for Clinical Science)
Organization: UMDNJ
Phone: 732-235-6783
EMail: goodin@umdnj.edu
Layout table for additonal information
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