Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin
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| Tracking Information | |||||
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| First Received Date ICMJE | February 9, 2009 | ||||
| Last Updated Date | November 12, 2012 | ||||
| Start Date ICMJE | April 2007 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
the Best Overall Clinical Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE |
the best overall clinical response (complete response and partial response) rates. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00840450 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin | ||||
| Official Title ICMJE | Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin | ||||
| Brief Summary | This study is designed to determine whether the combination treatment of Paclitaxel and Gleevec on recurrent ovarian cancer patients or other cancers of mullerian origin will generate better clinical response than Paclitaxel alone. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Ovarian Cancer | ||||
| Intervention ICMJE | Drug: Gleevec/Paclitaxel
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. Other Names:
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| Study Arm (s) | Experimental: Paclitaxel + Imatinib Mesylate (Gleevec)
Intervention: Drug: Gleevec/Paclitaxel |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 14 | ||||
| Completion Date | October 2012 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00840450 | ||||
| Other Study ID Numbers ICMJE | 06-226, CSTI57BUS224 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | New York University School of Medicine | ||||
| Study Sponsor ICMJE | New York University School of Medicine | ||||
| Collaborators ICMJE | Novartis | ||||
| Investigators ICMJE |
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| Information Provided By | New York University School of Medicine | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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