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
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: oxaliplatin||Phase 2|
- Determine the therapeutic activity of oxaliplatin in patients with advanced or metastatic breast cancer following failure of anthracycline/taxane based chemotherapy.
- Determine objective response, duration of response, and time to progression in these patients when treated with this regimen.
- Determine the acute side effects of this regimen in these patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Official Title:||Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy|
|Study Start Date :||May 2000|
|Actual Primary Completion Date :||May 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006121
|Kaiser Franz Josef Hospital|
|Vienna (Wien), Austria, A-1100|
|Institut Jules Bordet|
|Brussels (Bruxelles), Belgium, 1000|
|CHU de la Timone|
|Marseille, France, 13385|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Centre Eugene Marquis|
|Rennes, France, 35064|
|Hamburg, Germany, D-20246|
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Schneider Children's Medical Center of Israel|
|Petah-Tikva, Israel, 49202|
|Institute of Oncology, Ljubljana|
|Ljubljana, Slovenia, Sl-1000|
|Beatson Oncology Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||Pierre Fumoleau, MD, PhD||Centre Georges Francois Leclerc|