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Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin

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ClinicalTrials.gov Identifier: NCT00840450
Recruitment Status : Terminated (Due to slow accrual)
First Posted : February 10, 2009
Results First Posted : September 26, 2011
Last Update Posted : November 19, 2012
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Intervention Drug: Gleevec/Paclitaxel
Enrollment 14
Recruitment Details 14 patients were enrolled into this study from April 2007 to August 2009 from New York University medical center and affiliated hospitals. Only 12 were evaluable since 2 patients never received treatment because of rapid symptomatic deterioration.
Pre-assignment Details  
Arm/Group Title Paclitaxel and Imatinib Mesylate (Gleevec)
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 12
Completed 9
Not Completed 3
Reason Not Completed
Adverse Event             1
Lack of Efficacy             2
Arm/Group Title Paclitaxel and Imatinib Mesylate (Gleevec)
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  66.7%
>=65 years
4
  33.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
61  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
12
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
Platinum Sensitivity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants
Resistant 10
Sensitive 2
1.Primary Outcome
Title the Best Overall Clinical Response
Hide Description This is defined as the percentage of participants who had either a complete response (CR) or a partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease or CA-125 criteria for non-measurable disease. The response is evaluated at 12 weeks of treatment.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is based on the intent-to-treat population.
Arm/Group Title Paclitaxel and Imatinib Mesylate (Gleevec)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
33
2.Secondary Outcome
Title Progression-free-tolerance
Hide Description This is defined as the percentage of participants who continued on treatment with no progression at 12 weeks since the start of treatment.A patient will be considered to have progression-free-tolerance if she does not drop out due to toxicity and does not have disease progression or die by the completion of 12 weeks on treatment.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Based on intent-to-treat population.
Arm/Group Title Paclitaxel and Imatinib Mesylate (Gleevec)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
75
3.Secondary Outcome
Title Progression-free-survival at 12 Months
Hide Description This defined as the percentage of participants who had progression free survival at 12 months from the beginning of the treatment.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Based on intent-to-treat population.
Arm/Group Title Paclitaxel and Imatinib Mesylate (Gleevec)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
17
Time Frame treatment period (up to 5 months) plus 30 days after treatment or until the the adverse events have resolved or returned to pretreatment values or deemed irreversible.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paclitaxel and Imatinib Mesylate (Gleevec)
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Paclitaxel and Imatinib Mesylate (Gleevec)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Paclitaxel and Imatinib Mesylate (Gleevec)
Affected / at Risk (%) # Events
Total   3/12 (25.00%)    
Blood and lymphatic system disorders   
Neutropenia  1  2/12 (16.67%)  2
Thrombocytopenia  1  1/12 (8.33%)  1
Gastrointestinal disorders   
Diarrhea  1  1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paclitaxel and Imatinib Mesylate (Gleevec)
Affected / at Risk (%) # Events
Total   11/12 (91.67%)    
Blood and lymphatic system disorders   
Anemia  1  11/12 (91.67%) 
Neutropenia  1  5/12 (41.67%) 
Thrombocytopenia  1  1/12 (8.33%) 
Cardiac disorders   
Palpitation  1  4/12 (33.33%) 
Shortness of breath  1  1/12 (8.33%) 
Gastrointestinal disorders   
Diarrhea  1  5/12 (41.67%) 
Mucostitis  1  1/12 (8.33%) 
Nausea  1  10/12 (83.33%) 
Vomiting  1  5/12 (41.67%) 
General disorders   
Alopecia  1  5/12 (41.67%) 
Edema  1  2/12 (16.67%) 
Fatigue  1  9/12 (75.00%) 
Headache  1  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  3/12 (25.00%) 
Nervous system disorders   
Neuropathy  1  7/12 (58.33%) 
Skin and subcutaneous tissue disorders   
skin toxicity  1  2/12 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (Unspecified)
Premature closure led to small numbers of subjects analyzed (12 out of 50 targeted accrual number).
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: Franco Muggia, MD
Organization: NYU Cancer Institute
Phone: 212-263-6485
EMail: franco.muggia@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00840450    
Other Study ID Numbers: 06-226
CSTI57BUS224 ( Other Identifier: Novartis )
First Submitted: February 9, 2009
First Posted: February 10, 2009
Results First Submitted: August 18, 2011
Results First Posted: September 26, 2011
Last Update Posted: November 19, 2012