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Tracking Information | |||||||||||||
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First Received Date † | September 7, 2004 | ||||||||||||
Last Updated Date | July 23, 2008 | ||||||||||||
Start Date † | October 2004 | ||||||||||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00091182 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † | |||||||||||||
Original Secondary Outcome Measures † | |||||||||||||
Descriptive Information | |||||||||||||
Brief Title † | Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment | ||||||||||||
Official Title † | A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors | ||||||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well oxaliplatin works in treating young patients with recurrent solid tumors that have not responded to previous treatment. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease type. Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study. |
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Study Phase | Phase II | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Open Label | ||||||||||||
Condition † |
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Intervention † | Drug: oxaliplatin | ||||||||||||
Study Arms / Comparison Groups | |||||||||||||
Publications * | |||||||||||||
* 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 † | Completed | ||||||||||||
Estimated Enrollment † | 180 | ||||||||||||
Completion Date | |||||||||||||
Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria † | 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 | up to 21 Years | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | United States, Australia, Canada, New Zealand, Puerto Rico | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00091182 | ||||||||||||
Responsible Party | |||||||||||||
Secondary IDs †† | COG-ADVL0421 | ||||||||||||
Study Sponsor † | Children's Oncology Group | ||||||||||||
Collaborators †† | National Cancer Institute (NCI) | ||||||||||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||
Verification Date | September 2006 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |