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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 6, 2006 | ||||||||
| Last Updated Date | October 16, 2009 | ||||||||
| Start Date ICMJE | October 2005 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Median progression-free survival [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Median progression-free survival | ||||||||
| Change History | Complete list of historical versions of study NCT00288015 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Bevacizumab in Treating Patients With Angiosarcoma | ||||||||
| Official Title ICMJE | An Open Label Multicenter Phase II Study of Bevacizumab for the Treatment of Angiosarcoma | ||||||||
| Brief Summary | RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with angiosarcoma. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is an open-label, multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 to 4 months for 2 years. PROJECTED ACCRUAL: A total of 31 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Open Label | ||||||||
| Condition ICMJE | Sarcoma | ||||||||
| Intervention ICMJE | Biological: bevacizumab | ||||||||
| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 31 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | |||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00288015 | ||||||||
| Responsible Party | Mark Agulnik, Robert H. Lurie Comprehensive Cancer Center at Northwestern University | ||||||||
| Study ID Numbers ICMJE | CDR0000456253, NU-04S1 | ||||||||
| Study Sponsor ICMJE | Robert H. Lurie Cancer Center | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | July 2009 | ||||||||
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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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