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| Tracking Information | |||||
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| First Received Date ICMJE | May 13, 2002 | ||||
| Last Updated Date | January 28, 2009 | ||||
| Start Date ICMJE | May 2002 | ||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00036751 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer | ||||
| Official Title ICMJE | A Phase II Trial Of STI571 For The Treatment Of Platinum And Paclitaxel Refractory Stage III And IV Epithelial Ovarian Cancer And Primary Peritoneal Cancer | ||||
| Brief Summary | RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer that has not responded to previous treatment. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: imatinib mesylate | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Alberts DS, Liu PY, Wilczynski SP, Jang A, Moon J, Ward JH, Beck JT, Clouser M, Markman M. Phase II trial of imatinib mesylate in recurrent, biomarker positive, ovarian cancer (Southwest Oncology Group Protocol S0211). Int J Gynecol Cancer. 2007 Mar 1; [Epub ahead of print] | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Female | ||||
| Ages | |||||
| 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 ID ICMJE | NCT00036751 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000069319, SWOG-S0211 | ||||
| Study Sponsor ICMJE | Southwest Oncology Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | August 2004 | ||||
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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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