Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
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First Received Date ICMJE | March 3, 2005 | ||||||||||||||||||||||||
Last Updated Date | July 31, 2010 | ||||||||||||||||||||||||
Start Date ICMJE | July 2005 | ||||||||||||||||||||||||
Primary Completion Date | |||||||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Response rate (confirmed complete response and partial response) [ Designated as safety issue: No ] | ||||||||||||||||||||||||
Original Primary Outcome Measures ICMJE |
Response rate (confirmed complete response and partial response) | ||||||||||||||||||||||||
Change History | Complete list of historical versions of study NCT00104949 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||||||||||||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||||||
Brief Title ICMJE | Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma | ||||||||||||||||||||||||
Official Title ICMJE | Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma | ||||||||||||||||||||||||
Brief Summary | RATIONALE: Monoclonal antibodies, such as trastuzumab, 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. Trastuzumab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well trastuzumab works in treating patients with locally advanced or metastatic synovial sarcoma. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a pilot, multicenter study. Patients receive trastuzumab (Herceptin^®) IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 weeks until disease progression and then every 6 months for up to 2 years from study entry. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-40 months. |
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Study Type ICMJE | Interventional | ||||||||||||||||||||||||
Study Phase | Phase 2 | ||||||||||||||||||||||||
Study Design ICMJE | Primary Purpose: Treatment | ||||||||||||||||||||||||
Condition ICMJE | Sarcoma | ||||||||||||||||||||||||
Intervention ICMJE | Biological: trastuzumab | ||||||||||||||||||||||||
Study Arm (s) | |||||||||||||||||||||||||
Publications * | |||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||
Estimated Enrollment ICMJE | 40 | ||||||||||||||||||||||||
Completion Date | |||||||||||||||||||||||||
Primary Completion Date | |||||||||||||||||||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
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 | |||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||
NCT Number ICMJE | NCT00104949 | ||||||||||||||||||||||||
Other Study ID Numbers ICMJE | CDR0000413703, SWOG-S0346 | ||||||||||||||||||||||||
Has Data Monitoring Committee | |||||||||||||||||||||||||
Responsible Party | |||||||||||||||||||||||||
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 | December 2006 | ||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |