Oxaliplatin in Treating Women With Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy
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ClinicalTrials.gov Identifier: NCT00006121 |
Recruitment Status
:
Terminated
(low accrual)
First Posted
: October 8, 2003
Last Update Posted
: July 24, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | August 3, 2000 | |||
First Posted Date ICMJE | October 8, 2003 | |||
Last Update Posted Date | July 24, 2012 | |||
Study Start Date ICMJE | May 2000 | |||
Actual Primary Completion Date | May 2002 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00006121 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Oxaliplatin in Treating Women With Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy | |||
Official Title ICMJE | Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy | |||
Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating women who have advanced or metastatic breast cancer that has not responded to previous chemotherapy. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients receive oxaliplatin IV over 2 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression and then every 3 months for survival. PROJECTED ACCRUAL: A total of 27-40 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE | Breast Cancer | |||
Intervention ICMJE | Drug: oxaliplatin | |||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* 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 | Terminated | |||
Actual Enrollment ICMJE |
18 | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date | Not Provided | |||
Actual Primary Completion Date | May 2002 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Belgium, France, Germany, Israel, Slovenia, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00006121 | |||
Other Study ID Numbers ICMJE | EORTC-16001-10005 EORTC-16001 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | European Organisation for Research and Treatment of Cancer - EORTC | |||
Study Sponsor ICMJE | European Organisation for Research and Treatment of Cancer - EORTC | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | European Organisation for Research and Treatment of Cancer - EORTC | |||
Verification Date | July 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |