Pyroxamide in Treating Patients With Advanced Cancer
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First Received Date ICMJE | August 5, 2002 | ||||
Last Updated Date | February 19, 2012 | ||||
Start Date ICMJE | April 2002 | ||||
Primary Completion Date | |||||
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Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00042900 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Pyroxamide in Treating Patients With Advanced Cancer | ||||
Official Title ICMJE | A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies | ||||
Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of pyroxamide in treating patients who have advanced cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients receive pyroxamide IV continuously over 5-7 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of pyroxamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for resolution of adverse events. PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Primary Purpose: Treatment | ||||
Condition ICMJE |
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Intervention ICMJE | Drug: pyroxamide | ||||
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 | ||||
Enrollment ICMJE | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
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 Number ICMJE | NCT00042900 | ||||
Other Study ID Numbers ICMJE | CDR0000069483, MSKCC-99090, NCI-2110 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | May 2007 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |