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Tracking Information | |||||
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First Received Date † | March 29, 2006 | ||||
Last Updated Date | April 14, 2009 | ||||
Start Date † | December 2005 | ||||
Current Primary Outcome Measures † |
Objective response rate (complete or partial response) [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00309946 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | AZD2171 in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery | ||||
Official Title † | Phase II Study of AZD2171 (NSC#732208) in Patients With Malignant Mesothelioma | ||||
Brief Summary | RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well AZD2171 works in treating patients with malignant mesothelioma that cannot be removed by surgery. |
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Detailed Description | OBJECTIVES: Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study. Patients receive oral ADZ2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection periodically during study for biomarker and optional pharmacogenomic correlative studies. After completion of study treatment, patients are followed for up to 8 weeks. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † | Malignant Mesothelioma | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* 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 † | Recruiting | ||||
Enrollment † | 50 | ||||
Completion Date | |||||
Estimated Primary Completion Date | October 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00309946 | ||||
Responsible Party | Everett E. Vokes, University of Chicago Cancer Research Center | ||||
Secondary IDs †† | UCCRC-14203B, NCI-7103 | ||||
Study Sponsor † | University of Chicago | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | June 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |