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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003730 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized clinical trial to study the effectiveness of vinorelbine plus fluorouracil in treating women who have metastatic breast cancer that has been previously treated with at least one regimen of chemotherapy.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: fluorouracil Drug: vinorelbine ditartrate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Multicenter Randomized Trial, With Direct Individual Benefit, to Determine the Optimal Circadian Time of Vinorelbine Administration Combined With Chronomodulated Infusion of 5-Fluorouracil in Previously Treated Patients With Metastatic Breast Cancer |
| Estimated Enrollment: | 80 |
| Study Start Date: | December 1998 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior chemotherapy (second line vs third line) and participating center. Patients are randomized to 1 of 8 vinorelbine dosing times (0000, 0300, 0600, 0900, 1200, 1500, 1800, or 2100).
Patients receive vinorelbine IV over 20 minutes on days 1 and 6 and fluorouracil IV over 12 hours according to a chronomodulated delivery rate (2200 to 1000 with a maximum dose at 0400) on days 1-4. Treatment repeats every 3 weeks for at least 3 courses in the absence of unacceptable toxicity.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A minimum of 80 patients (10 per dosing time) will be accrued for this study.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormonal receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Belgium | |
| C.H.C - Asbl | |
| Liege, Belgium, B 4000 | |
| CHU Liege - Domaine Universitaire du Sart Tilman | |
| Liege, Belgium, B-4000 | |
| VZW Monica Campus Eeuwfeestkliniek | |
| Antwerpen, Belgium, 2010 | |
| France | |
| Centre de Lutte Contre le Cancer Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| Hopital Bellevue | |
| Saint Etienne, France, 42055 | |
| Centre Jean Perrin | |
| Clermont-Ferrand, France, 63011 | |
| Centre Rene Huguenin | |
| Saint Cloud, France, 92211 | |
| Centre Hospital Regional Universitaire de Limoges | |
| Limoges, France, 87042 | |
| Hopital Paul Brousse | |
| Villejuif, France, 94804 | |
| Hopital Perpetuel Secours | |
| Levallois-Perret, France, 92300 | |
| Hopital Saint-Louis | |
| Paris, France, 75475 | |
| Greece, Crete | |
| University Hospital of Heraklion | |
| Iraklion (Heraklion), Crete, Greece, 71110 | |
| Italy | |
| Azienda Ospedale S. Luigi - Universita Di Turin | |
| Orbassano, (Torino), Italy, 10043 | |
| Ospedale San Carlo Borromeo | |
| Milano (Milan), Italy, 20153 | |
| Istituti Fisioterapici Ospitalieri - Roma | |
| Rome, Italy, 00161 | |
| Istituto per la Ricerca e Cura del Cancro | |
| Candiolo (Turin), Italy, 10180 | |
| Fondazione Salvatore Maugeri | |
| Pavia, Italy, I-27100 | |
| Investigator: | Bruno Coudert, MD | Centre de Lutte Contre le Cancer Georges-Francois Leclerc |
More Information
| Study ID Numbers: | CDR0000066843, EORTC-05971 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003730 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Breast Neoplasms Vinblastine Antimitotic Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Vinorelbine Therapeutic Uses Fluorouracil Tubulin Modulators Antineoplastic Agents, Phytogenic Breast Diseases |