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| Tracking Information | |||||
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| First Received Date ICMJE | April 9, 2007 | ||||
| Last Updated Date | April 22, 2009 | ||||
| Start Date ICMJE | February 2007 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Progression-free survival (PFS) rate at 18 weeks [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Progression-free survival (PFS) rate at 18 weeks | ||||
| Change History | Complete list of historical versions of study NCT00458913 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 | Bortezomib and Cisplatin as First-Line Therapy in Treating Patients With Malignant Mesothelioma | ||||
| Official Title ICMJE | Phase II Study of Bortezomib (VELCADE) With Cisplatin as First Line Treatment of Malignant Mesothelioma | ||||
| Brief Summary | RATIONALE: Bortezomib 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. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with cisplatin may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib together with cisplatin works as first-line therapy in treating patients with malignant mesothelioma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive cisplatin IV over 1 hour on day 1 and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically. PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label | ||||
| Condition ICMJE | Malignant Mesothelioma | ||||
| Intervention ICMJE |
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| 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 | 76 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | December 2009 (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 Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00458913 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000538677, EORTC-08052, JJPRD-26866138CAN2012, EUDRACT-2006-000009-51 | ||||
| Study Sponsor ICMJE | European Organization for Research and Treatment of Cancer | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 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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