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| Tracking Information | |||||
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| First Received Date ICMJE | September 10, 2003 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | March 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Response rate as measured by RECIST every 8 weeks [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Response rate as measured by RECIST every 8 weeks | ||||
| Change History | Complete list of historical versions of study NCT00068380 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Imatinib Mesylate in Treating Patients With Refractory Metastatic and/or Unresectable Stomach or Gastroesophageal Junction Cancer | ||||
| Official Title ICMJE | A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer | ||||
| Brief Summary | RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal junction cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk [chemonaïve] vs poor risk [1 prior chemotherapy regimen]). Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days. PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 1-1.5 years. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: imatinib mesylate | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 41 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| 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 ID ICMJE | NCT00068380 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000322257, CCC-PHII-37, 2004-01-09, NCI-5734 | ||||
| Study Sponsor ICMJE | California Cancer Consortium | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2006 | ||||
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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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