Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
david mccune, md, Madigan Army Medical Center
ClinicalTrials.gov Identifier:
NCT00928642
First received: June 25, 2009
Last updated: October 20, 2014
Last verified: October 2014
Results First Received: April 5, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Primary Peritoneal Cancer
Interventions: Drug: imatinib mesylate by mouth
Drug: Gemcitabine Intravenous

  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

Three subjects were enrolled at Brooke Army Medical Center. Five subjects were enrolled at Madigan Army Medical Center.

Seven of eght subjects are deceased as of 4/4/2013.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
none

Reporting Groups
  Description
Oral Imatinib Plus Gemcitabine Open label, non-randomized, single treatment group.

Participant Flow:   Overall Study
    Oral Imatinib Plus Gemcitabine  
STARTED     8  
COMPLETED     8 [1]
NOT COMPLETED     0  
[1] 1 subject withdrew after 1st cycle but before disease assessment. 7 of 8 are evaluable for response



  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
Treatment Open label, non-randomized, single treatment group.

Baseline Measures
    Treatment  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  61.5  ± 7.3  
Gender  
[units: participants]
 
Female     8  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma.   [ Time Frame: Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years. ]

2.  Primary:   To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria   [ Time Frame: Until disease progression or unacceptable toxicity ]

3.  Secondary:   Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment.   [ Time Frame: Subjects treated until progression of disease or unacceptable toxicity. no maximum dose was specified ]

4.  Secondary:   To Determine the Distribution of the Overall Survival   [ Time Frame: Until death ]

5.  Secondary:   To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial)   [ Time Frame: until disease progression or unacceptable toxicity ]

6.  Secondary:   To Assess the Effects of Prognostic Variables; Initial Performance Status; Platinum Sensitivity, and Mucinous (or Clear Cell)Histology on Progression-free Survival Overall.   [ Time Frame: Until disease progression ]


  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
This study was terminated due to a combination of poor accrual and lack of evidence of benefit.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: COL David E. McCune, MD, MC
Organization: Madigan Army Medical Center
phone: 253-968-1155
e-mail: david.e.mccune.mil@mail.mil


No publications provided


Responsible Party: david mccune, md, Madigan Army Medical Center
ClinicalTrials.gov Identifier: NCT00928642     History of Changes
Other Study ID Numbers: CSTI571BUS241, MAMC#206126
Study First Received: June 25, 2009
Results First Received: April 5, 2013
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government