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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006121 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: oxaliplatin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Bidimensionally measurable disease
Must have failed prior anthracycline/taxane based chemotherapy as defined by one of the following:
Hormonal receptor status:
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:
Contacts and Locations| Austria | |
| Kaiser Franz Josef Hospital | |
| Vienna (Wien), Austria, A-1100 | |
| Belgium | |
| Institut Jules Bordet | |
| Brussels (Bruxelles), Belgium, 1000 | |
| France | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| CRLCC Nantes - Atlantique | |
| Nantes-Saint Herblain, France, 44805 | |
| Centre Eugene Marquis | |
| Rennes, France, 35064 | |
| Germany | |
| Universitats-Krankenhaus Eppendorf | |
| Hamburg, Germany, D-20246 | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Schneider Children's Medical Center of Israel | |
| Petah-Tikva, Israel, 49202 | |
| Slovenia | |
| Institute of Oncology, Ljubljana | |
| Ljubljana, Slovenia, Sl-1000 | |
| United Kingdom | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Study Chair: | Pierre Fumoleau, MD, PhD | Centre de Lutte Contre le Cancer Georges-Francois Leclerc |
More Information
| ClinicalTrials.gov Identifier: | NCT00006121 History of Changes |
| Other Study ID Numbers: | CDR0000068135, EORTC-16001 |
| Study First Received: | August 3, 2000 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
stage III breast cancer stage IV breast cancer recurrent breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Oxaliplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |