Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin
|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
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Gleevec/Paclitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin|
|Study Start Date :||April 2007|
|Primary Completion Date :||April 2010|
|Study Completion Date :||October 2012|
U.S. FDA Resources
|Experimental: Paclitaxel + Imatinib Mesylate (Gleevec)||
One treatment cycle:
Gleevec: 300 mg twice a day orally for 4 consecutive days, then off for 3 days, every 7 days for 28 days.
Paclitaxel: 80 mg/m^2/week intravenously, 3 weeks on, one week off, every 28 days.
After 3 treatment cycles, decision made to continue or not with the combination based on tolerance and lack of progression.
- the Best Overall Clinical Response [ Time Frame: 12 weeks ]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.
- Progression-free-tolerance [ Time Frame: 12 weeks ]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.
- Progression-free-survival at 12 Months [ Time Frame: up to 12 months ]This defined as the percentage of participants who had progression free survival at 12 months from the beginning of the treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840450
|United States, New York|
|NYU cancer center|
|New York, New York, United States, 10016|
|Principal Investigator:||Franco M Muggia, MD||New York University School of Medicine|