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Trial record 81 of 278 for:    prostate cancer AND localized | ( Map: United States )

Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00500110
Recruitment Status : Completed
First Posted : July 12, 2007
Results First Posted : August 4, 2011
Last Update Posted : April 28, 2015
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Docetaxel
Drug: Imatinib Mesylate
Drug: Leuprolide
Drug: Goserelin Acetate
Enrollment 39
Recruitment Details Recruitment at Medical Clinic from 6/13/03 to 11/29/04.
Pre-assignment Details  
Arm/Group Title Hormonal Ablation, Imatinib + Docetaxel
Hide Arm/Group Description Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
Period Title: Overall Study
Started 39
Completed 36
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Arm/Group Title Hormonal Ablation, Imatinib + Docetaxel
Hide Arm/Group Description Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
<=18 years
0
   0.0%
Between 18 and 65 years
33
  84.6%
>=65 years
6
  15.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
0
   0.0%
Male
39
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  10.3%
White
35
  89.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants
39
1.Primary Outcome
Title Number of Participants Achieving Pathological Complete Response
Hide Description Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.
Time Frame Every 3 months for 1 year, then every 6 months until disease progression or death
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol.
Arm/Group Title Treatment
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
0
Time Frame 6 years and 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hormonal Ablation, Imatinib + Docetaxel
Hide Arm/Group Description Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
All-Cause Mortality
Hormonal Ablation, Imatinib + Docetaxel
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Hormonal Ablation, Imatinib + Docetaxel
Affected / at Risk (%) # Events
Total   9/36 (25.00%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  1/36 (2.78%)  1
Cardiac disorders   
acute coronary syndrome  1  1/36 (2.78%)  1
Gastrointestinal disorders   
vomiting  1  1/36 (2.78%)  1
General disorders   
Fatigue  1  1/36 (2.78%)  1
fever  1  1/36 (2.78%)  1
Investigations   
Alanine aminotransferase  1  1/36 (2.78%)  1
neutrophil count decreased  1  1/36 (2.78%)  1
Vascular disorders   
thrombosis/embolism  1  2/36 (5.56%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Hormonal Ablation, Imatinib + Docetaxel
Affected / at Risk (%) # Events
Total   36/36 (100.00%)    
Gastrointestinal disorders   
diarrhea  1  4/36 (11.11%)  8
General disorders   
fatigue  1  16/36 (44.44%)  22
Investigations   
alanine transaminase  1  6/36 (16.67%)  6
Respiratory, thoracic and mediastinal disorders   
dyspnea  1  5/36 (13.89%)  5
Skin and subcutaneous tissue disorders   
rash  1  9/36 (25.00%)  13
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
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: Quality Assurance Specialist
Organization: MD Anderson Cancer Center
Phone: 713-563-1602
EMail: caperez@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00500110     History of Changes
Other Study ID Numbers: ID03-0112
First Submitted: July 10, 2007
First Posted: July 12, 2007
Results First Submitted: July 11, 2011
Results First Posted: August 4, 2011
Last Update Posted: April 28, 2015