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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 8, 2003 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | June 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00064324 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma | ||||
| Official Title ICMJE | A Phase II Study Of Perifosine In Soft Tissue Sarcoma | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have advanced soft tissue sarcoma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients receive a loading dose of oral perifosine every 6 hours for a total of 4 doses on day 1 and once daily on days 2-28 of course 1 only. For all subsequent courses, patients receive oral perifosine once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years. PROJECTED ACCRUAL: A total of 17-46 patients will be accrued for this study within 9-12 months. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Sarcoma | ||||
| Intervention ICMJE | Drug: perifosine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Bailey HH, Mahoney MR, Ettinger DS, Maples WJ, Fracasso PM, Traynor AM, Erlichman C, Okuno SH. Phase II study of daily oral perifosine in patients with advanced soft tissue sarcoma. Cancer. 2006 Nov 15;107(10):2462-7. | ||||
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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 | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
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 | NCT00064324 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000315381, MAYO-MC0276, NCI-5972 | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2004 | ||||
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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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